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PubMed1998

Prostate cancer detection in candidates for open prostatectomy.

PURPOSE: We determine the incidence of biopsy detectable prostate cancer in men with clinical benign prostatic hyperplasia (BPH) and prostate specific antigen (PSA) elevation who are candidates for open prostatectomy, and the histology of prostatic tissue of men who underwent surgery. MATERIALS AND METHODS: Sextant peripheral zone prostate biopsies were performed in 128 consecutive men with obstructive voiding symptoms who had digital rectal examination not suspicious for cancer, PSA greater than 4.0 ng./ml. and prostate volume 75 ml. or greater. Of the patients 59 also underwent transition zone biopsy. Median PSA was 9.9 ng./ml. (range 4.1 to 80.0), median prostate volume was 92 ml. (range 75 to 220), median PSA density was 0.10 ng./ml./ml. (range 0.03 to 0.80) and median percent free PSA in 43 patients was 23.6 (range 8.8 to 41.3). RESULTS: Of the 128 patients 16 (13%) had malignant biopsy including 1 who had cancer detected with transition zone biopsy only. Gleason score of tumors ranged from 4 to 8 (median 5). Of 57 patients who underwent prostatectomy 6 (11%) had stage T1a and 2 (4%) had stage T1b cancer. Among men without an indwelling urethral catheter due to acute urinary retention mean PSA, PSA density and percent free PSA were not significantly different in those with benign and malignant biopsies and/or prostatectomy specimens. CONCLUSIONS: Greater than 10% of men with PSA elevation who are potential candidates for open prostatectomy will have biopsy detectable prostate cancer. This diagnostic yield, while lower than that reported for unselect men with normal digital rectal examination and PSA elevation, may justify preoperative peripheral zone biopsy to avoid surgical misadventure during open enucleation. Among patients with benign peripheral zone biopsy there is a less than 5% prevalence of large volume tumors that may complicate open enucleation.

Aged↗
PubMed1992

Prostate-specific antigen levels in 1695 men without evidence of prostate cancer. Findings of the American Cancer Society National Prostate Cancer Detection Project.

The American Cancer Society National Prostate Cancer Detection Project is a prospective, multidisciplinary, and multicenter trial to assess the potential for early detection of prostate cancer by transrectal ultrasonography (TRUS), digital rectal examination (DRE), and serum prostate-specific antigen assay (PSA). By November 1990, 2805 men between the ages of 55 and 70 years with no known signs or symptoms of prostate cancer were enrolled in the study, which is planned to run for 5 years. Annual TRUS, DRE, and PSA tests were done on these subjects, and biopsies were recommended for suspicious lesions when detected. To study the performance of PSA testing in presumed normal subjects, all men were eliminated who had (1) prostate cancer detected on their initial examinations and proven by biopsy or (2) cancer detected during the year or subsequent examinations. Additionally, all men with TRUS or DRE findings that were interpreted as suspicious for cancer but who are being followed and have not yet had biopsies done were removed from this series. This left a unique, extensively screened group of 1695 men who were free of prostate cancer, as far as could be determined. Analyses of the PSA levels in this large population in the appropriate age range for increasing risk of prostate cancer revealed several important findings. First, there was a direct relationship between serum PSA levels and estimated prostate volume for both the currently available monoclonal and polyclonal PSA assays. Individuals with benign prostatic hyperplasia and larger gland volume have a higher normal limit of PSA than men with normal gland volume. Second, analyses showed no relationship between age and PSA levels or between symptoms of prostatism and PSA levels independent of gland enlargement. It was concluded that volume-adjusted upper limits of normal PSA can be determined for different levels of specificity desired. This information may be applicable to the use of PSA in men not already suspected of having prostate cancer and may increase its effectiveness as a tool for early detection.

Age Factors↗
PubMed2000

Would prostate cancer detected by screening with prostate-specific antigen develop into clinical cancer if left undiagnosed? A comparison of two population-based studies in Sweden.

OBJECTIVE: To assess the risk of over-diagnosing and over-treating prostate cancer if population-based screening with serum prostate-specific antigen (PSA) is instituted. PATIENTS AND METHODS: From a serum bank stored in 1980, PSA was analysed in 658 men with no previously known prostate cancer from a well-defined cohort from Göteborg, Sweden (men born in 1913); the incidence of clinical prostate cancer was registered until 1995. From the same area, and with the same selection criteria, another cohort of 710 men born in 1930-31, who in 1995 accepted an invitation for PSA screening, was also analysed. RESULTS: Of men born in 1913, 18 (2.7%) had died from prostate cancer and the cumulative probability of being diagnosed with clinical prostate cancer was 11.1% (5.0% in those with a PSA level of < 3 ng/mL vs 32.9% in those with a PSA level of > 3 ng/mL, P < 0.01). The mean lead-time from increased PSA (> 3 ng/mL) to clinical diagnosis was 7 years. The prostate cancer detection rate in men born in 1930-31 was 4.4% (22% among those with increased PSA levels) and 30 of 31 detected cancers were clinically localized. CONCLUSIONS: Screening and sextant biopsies resulted in a lower detection rate (22%) than the cumulative risk of having clinical prostate cancer (33%) in men with increased PSA levels, indicating that under-diagnosis rather than over-diagnosis is the case at least with 'one-time' screening. Even if the stage distribution in screening-detected cancers seems promising (and thus may result in reduced mortality) it is notable that screening 67-year-old men will result in treatment a mean of 7 years before clinical symptoms occur and only one in four men anticipated to develop prostate cancer will die from the disease within 15 years. Large randomized screening trials seem mandatory to further explore the benefits and hazards of PSA screening.

Aged↗
PubMed1996

Development of Molecular Approaches to Early Lung Cancer Detection.

Lung cancer has been particularly recalcitrant to standard therapeutic interventions. Improvement in the outcome for this disease requires the ability to identify the disease while it is still localized in the airways. Usually, radiation therapy to eliminate this disease fails because of progression of the cancer outside the radiation treatment ports. This is a failure of the diagnostic modalities to detect the extent of the cancer, not a failure of the radiation. With new epithelial-directed diagnostics, the ability to detect the premetastatic phase of lung cancer is emerging. Evolution of the screening infrastructure will be required to allow percolation of this technology out to the medical community, so that a benefit in cancer mortality reduction can be achieved. Some development issues will have to be resolved. Considering our fragmentary understanding of pulmonary carcinogenesis, the heterogeneity of lung cancer suggests that a panel of biomarkers instead of a single marker will be required to clarify the status of an individual's epithelium. However, the data output from multiplexed bioassays performed on large clinical populations will require better integration of information technology to optimize analysis and reporting of test results. An important new area for outcomes research is the systematic analysis of population screening approaches. With population sampling algorithms, selective screening. This type of research requires careful clinical validation. Finally, the general acceptance of population-based screening will be determined by the availability of effective interventions to complement the new diagnostic tools. New measures to prevent the progression of early cancer will be discussed.

Journal Article↗
PubMed2006

A cost-effective algorithm for hereditary nonpolyposis colorectal cancer detection.

Colorectal cancer with microsatellite instability (MSI) may occur sporadically or be inherited in cases of hereditary nonpolyposis colorectal cancer (HNPCC) syndrome. However, there is no consensus as to which patients must be tested and how to test MSI. In this study, MSI was tested by immunohistochemical analysis and by polymerase chain reaction in 148 cases of colorectal cancer, and methylation of the hMLH1 promoter was examined. MSI status was correlated with tumor phenotype. We found that localization, tumor infiltrating lymphocytes, and mucinous differentiation were predictive of high-frequency MSI (MSI-H) colorectal cancer and might be used to select cases for MSI analysis. Immunohistochemical analysis detected most MSI-H colorectal cancer and might constitute the first step in MSI detection. Absence of hMLH1 promoter methylation in MSI-H colorectal cancer could be predictive of hereditary colorectal cancer, and, hence, methylation analysis might constitute the second step in the identification of patients with HNPCC.

Adaptor Proteins, Signal Transducing↗
PubMedDate not supplied

The early breast cancer detection program of the Israel Cancer Association: a retrospective evaluation.

Between 1 January 1965 and 31 December 1975 82,262 women visited an early breast cancer detection center at least once. Subsequent to the visit 1,295 women were found to have breast cancer. The observed survival of these 1,295 patients (the study group) was compared to that of two control groups: 1) all breast cancer patients diagnosed in Israel in the five years preceding the start of the Early Detection program (2,402), and 2) all breast cancer patients diagnosed while the Early Detection Program was in progress, but who never visited an early detection center (6,315). The stage distribution of the study group showed significantly more early-stage cases than controls. The observed survival of the study group was significantly longer than that of the control groups, irrespective of mode of referral of the former to the Early Detection Program (by invitation, self-referral, or doctor-referral). The observed survival of study patients was longer than that of controls within each stage group, although most differences were not statistically significant and relatively large number of "unknowns" in key variables may have introduced bias into the study results. Future programs of the Israel Cancer Association should have clearly stated and measurable objectives and built-in mechanisms for ongoing evaluation.

Aged↗
PubMed2006

A novel serum marker, total prostate secretory protein of 94 amino acids, improves prostate cancer detection and helps identify high grade cancers at diagnosis.

PURPOSE: New biomarkers for prostate cancer are needed. We determined whether a novel serum marker, total PSP94 can be used to accomplish these goals. MATERIALS AND METHODS: We conducted a case-control study of 1,212 men with no previous history of prostate cancer and who underwent a prostate biopsy from 1998 to 2000 because of an increased PSA or an abnormal DRE. Serum PSP94 levels were assessed using a sandwich enzyme-linked immunosorbent assay technique. Cases were patients with prostate cancer, and controls were patients who had no evidence of cancer. Multivariate logistic regression analysis was used to determine whether or not PSP94 levels improved the predictive value for prostate cancer. RESULTS: Of the 1,212 men 596 (49.2%) had cancer detected. The median PSP94 level was significantly lower among cases (2.60 ng/ml) than among controls (3.40 ng/ml, p <0.0001). The adjusted odds ratios for the presence of prostate cancer for patients with the lowest quartile of PSP94, compared to patients in the highest quartile was 2.70 (95% CI 1.8 - 4.0, p <0.0001). Among a subgroup of 649 men in whom PSA had a low predictive value (PSA less than 20 ng/ml, normal DRE and less than 70 years), 260 (40.1%) were found to have cancer. In this subgroup total PSP94 levels helped discriminate between patients with high grade disease (Gleason score 8 or more, median 1.90 ng/ml), moderate grade disease (Gleason score 7, median 2.34 ng/ml) and low grade disease (Gleason score 6 or less, median 2.60 ng/ml, p = 0.007). PSA and the FTPSA were not able to distinguish between patients with different grades in this group. CONCLUSIONS: Patients with low total PSP94 levels had a high probability for having prostate cancer detected at biopsy. The total PSP94 level was able to help identify patients with high grade disease among a subset of patients in whom PSA and FTPSA are least informative.

Adult↗
PubMed2004

Breast cancer detection rates, and standardised detection ratios for prevalence screening in the New Zealand breast cancer screening programme.

OBJECTIVES: To calculate breast cancer detection to expected incidence ratios and standardised detection ratios (SDRs) for the New Zealand breast cancer screening programme. METHOD: Breast cancer registrations for 1976-1999 were obtained from the New Zealand Cancer Registry. Using these registrations, the incidence in the absence of screening was projected for 1999 and 2000. These projections, and the invasive breast cancers detected in the New Zealand programme during 1999 and 2000, were used to calculate the detection to expected incidence ratios and SDRs. RESULTS: In 1999, the breast cancer detection rate was 5.6 per 1000 women screened. The expected incidence among these women in the absence of screening was 2.3 per 1000, a detection to expected incidence ratio of 2.4. The SDR was 0.84 (0.76-0.94). In 2000, the breast cancer detection rate was 6.0 per 1000 women screened. The expected incidence among these women in the absence of screening was 2.4 per 1000, a detection to expected incidence ratio of 2.5. The SDR was 0.90 (0.81 - 0.99). CONCLUSIONS: In the first two years of the national programme, detection to expected incidence ratios were less than 3.0, and the SDR results were below 1.0. It may be unrealistic to expect new screening programmes to achieve SDRs of 1.0 immediately. At a similar stage, the UK National Health Service Breast Cancer Screening Programme (NHSBSP) also reported SDRs of less than 1.0 and therefore lower than expected cancer detection rates compared with the Swedish Two-County trial. An encouraging finding was that SDRs in five of the six screening regions improved in the second year of the New Zealand screening programme.

Breast Neoplasms↗
PubMed1999

Breast cancers missed in the prevalent screening round: effect upon the size distribution of incident round detected cancers.

OBJECTIVE: To determine the effect of false negative screens (missed cancers) in the prevalent screening round on the relative size distribution of cancers detected at the first incident screen. SETTING: The Bolton, Bury, and Rochdale breast screening programme. METHODS: One hundred and three breast cancers detected in the first incident round of screening were analysed. The previous (prevalent round) screening films taken between two and four years earlier were subjected to blinded review and classified as either true negatives (no significant abnormality visible) or false negatives (a suspicious abnormality visible at the site of the subsequently detected cancer). The pathological size, type, and grade (where appropriate) of the cancers were recorded. RESULTS: Fifty one of the 103 cancers (49%) detected in the first incident round screen measured < 15 mm in diameter. A total of 32 cases were classified as false negatives. Of these, 12 (38%) measured < 15 mm in diameter. If all the false negative cancers had been detected at the prevalent screen, 39 (55%) of the remaining 71 cancers detected in the first incident round screen would have measured < 15 mm. A relative excess of lobular carcinomas was found among the false negatives. CONCLUSIONS: The findings suggest that although false negative screens in the prevalent round increase the number of cancers available for detection at the first incident round screen, many of these cancers are still < 15 mm in diameter at detection. Cancer detection performance in the prevalent screening round has only a minor influence on the relative proportion of small and large cancers detected at the first incident round screen.

Breast Neoplasms↗
PubMed1993

Quality assurance and cancer detection rates in a provincial screening mammography program. Work in progress.

In 1990, a provincial screening program was inaugurated in Alberta, a Canadian province of 2.4 million people. The goal of the program is to decrease the number of deaths from breast cancer by 30% in women aged 50-69 years. In the first 18 months of program operations, efforts were concentrated on high levels of quality assurance in all areas of program activities. In particular, the abnormality referral rates, cancer detection rates, and size and stage of mammographically detected cancers were evaluated. Of the 9,553 women seen, 8,524 were between the ages of 50 and 69 years. Reported abnormality rates were initially more than 16%, but were brought down steadily to less than 5%. Cancer detection rates increased with age, ranging from 1.9 cancers detected per 1,000 women aged 40-49 years to 14.1 cancers per 1,000 women aged 70 years and older. Forty-one of the 61 cancers detected (67%) were less than 1.5 cm in diameter. Forty-three of the 52 cancers (83%) in which the nodal status was known were node negative. At the conclusion of the first 18 months of operation, interpretation parameters were within the target zones expected for a population-based screening program.

Adult↗
PubMed1996

Characterization of the DD23 tumor-associated antigen for bladder cancer detection and recurrence monitoring. Marker Network for Bladder Cancer.

Bladder cancer detection, monitoring, and prevention represent major problems that could be addressed with sensitive and specific biomarkers. The antigen recognized by the DD23 antibody, previously developed against a tumor-related antigen, was partially biochemically characterized, and its sensitivity and specificity in cancer detection and recurrence monitoring was evaluated. Quantitative fluorescence image analysis was used to quantify antigen content in exfoliated urothelial cells in a cross-section of patients with bladder cancers of all grades and stages and control populations. The antigen was found in tumor cells as well as normal-appearing urothelial cells, suggesting it represents a marker induced by the altered growth factor environment of a cancer-containing bladder. When used as a quantitative marker, the sensitivity for bladder cancer detection was 85%, and the specificity was 95%. No significant difference was seen between symptomatic and asymptomatic control populations, including patients with previous bladder cancers in the absence of a recurrence. In bladder cancer recurrence monitoring, results were consistently negative until just before detection of a recurrence. The biomarker reflects a "field effect" that occurs very late in tumorigenesis and seems to represent events common to most cancers involving the genitourinary tract. Western blotting showed the antibody recognized a dimeric protein. DD23 quantification in single cells may be particularly useful in targeting cystoscopic intervention for recurrence monitoring and, because of its high specificity, could be a tool for bladder cancer screening in high-risk groups.

Antibodies, Monoclonal↗
PubMed2004

Polarized reflectance spectroscopy for pre-cancer detection.

Early detection of cancer and its curable precursors remains the best way to ensure patient survival and quality of life. Thus, highly selective, sensitive and cost-effective screening and diagnostic techniques to identify curable pre-cancerous lesions are desperately needed. Precancers are characterized by increased nuclear size, increased nuclear/cytoplasmic ratio, hyperchromasia and pleomorphism, which currently can only be assessed through an invasive, painful biopsy. Here, we describe the development of a non-invasive optical technique based on polarized reflectance spectroscopy that has the potential to provide in real time diagnostically useful information for pre-cancer detection. Our results demonstrate that polarized reflectance spectroscopy can be used to selectively detect the size-dependent scattering characteristics of nuclei in vivo. We gradually progress from cell suspensions to realistic three-dimensional tissue models of epithelium, then to cervical biopsies and, finally to in vivo studies on normal volunteers and clinical patients.

Animals↗
PubMed2003

Early diagnosis key to epithelial ovarian cancer detection.

Ovarian cancer is the fourth leading cause of cancer death for women and the most fatal of all gynecologic malignancies. Labeled "the whispering disease," ovarian cancer has an insidious onset with vague symptoms such as gastrointestinal upset, abdominal bloating and fatigue. Early diagnosis is often delayed and patients present with advanced disease. This article provides an overview of ovarian cancer, including epidemiology, classification, risk factors, screening and early detection.

Carcinoma, Endometrioid↗
PubMed2004

Outcome of patients with lung cancer detected incidentally.

Lung cancers in the early stages are sometimes detected incidentally. The aim of this study is to evaluate the outcome of patients with lung cancer detected incidentally and to compare to those in whom the malignancy was detected by symptoms. Untreated patients with lung cancer, who were admitted to our division over a 28-year period up to 2003, were analyzed with reference to their reasons for detection of the cancer. During the period, 1168 patients were diagnosed, and 173 (14.8%) of them were detected incidentally. As lung cancers detected incidentally were more often at operable stage (stage IA-IIIA) (p=0.0001), surgical treatment was chosen more frequently in the incidentally diagnosed group (p=0.0001). The outcome with lung cancer patients detected incidentally was more favorable than that of the patients detected by the symptoms (multivariate analysis, p=0.0001). The incidental detection of lung cancer contributes to improvement of the outcome. This study demonstrated a careful review of chest radiography obtained at routine or preoperative examination is important especially for the high-risk patients such as elderly and those with smoking history.

Adenocarcinoma↗
PubMedDate not supplied

Breast cancer detection by daughters of women with breast cancer.

PURPOSE: This study was conducted to determine the frequency of breast self-examination (BSE), clinical breast examination, and mammography of adult daughters of women with breast cancer. Additionally, the relationships among frequency of self-examination, clinical examination, perceived risk, fear of breast cancer, and frequency of talking with their mothers about breast cancer were assessed. METHODS: A retrospective, correlational descriptive design was used. Questionnaires were mailed to members of a breast cancer support group and to women diagnosed with breast cancer in one medical oncology practice. These women were asked to mail the questionnaires to their adult daughters. RESULTS: There was a significant relationship between frequency of BSE and frequency of talking with mothers about breast cancer. Frequency of self-examination was related inversely to fear of breast cancer. Fear of breast cancer appears to act as a barrier to action whereas frequency of talking with their mothers about breast cancer seems to act as a cue to action in support of the Health Belief Model. CLINICAL IMPLICATIONS: Healthcare providers should make every effort to optimize the practice of BSE in daughters of women with breast cancer. Only 52% reported performing BSE monthly, with the remaining 48% performing BSE less frequently or not at all. Thirty-one percent reported having no formal or printed instruction regarding BSE. Health professionals caring for women who have a family history of breast cancer should assess the educational needs of these women and provide opportunities for them to acquire and demonstrate skills. Periodic re-evaluation of BSE is needed to reinforce importance and demonstrate technique. The development of educational materials developed specifically for daughters of women with breast cancer may be useful in diminishing the perception of an unrealistically high risk of developing breast cancer. With the decrease in fear, which appears to be acting as a barrier to BSE in this group, better breast cancer detection practices in daughters may be realized. Counseling about realistic risk of developing breast cancer also may be useful in reducing the amount of fear of breast cancer in these women. This is an unnecessary burden for any woman to bear and may interfere with her optimal practice of breast cancer detection practices.

Adult↗
PubMed2000

A prospective randomized trial comparing 6 versus 12 prostate biopsy cores: impact on cancer detection.

PURPOSE: Several studies suggest that sextant transrectal ultrasound guided biopsy of the prostate provides insufficient material to detect all clinically important prostate cancer, and obtaining more biopsy cores may improve the cancer detection rate. We performed a prospective randomized trial comparing 6 to 12 prostate biopsy cores to determine the impact on the cancer detection rate. MATERIALS AND METHODS: We prospectively randomized 244 men, including 71 (29%) black men, with a mean age plus or minus standard deviation of 65 +/- 8 years to undergo biopsy with 6 or 12 peripheral zone tissue cores. In our study subjects serum total prostate specific antigen (PSA) was between 2.5 and 20 ng./ml., and/or digital rectal examination was suspicious for cancer. All men completed a self-administered pre-biopsy and 2 post-biopsy questionnaires at 2 and 4 weeks. Cancer detection rates were compared in the groups and correlated with race, biopsy history, digital rectal examination findings, total PSA, transrectal ultrasound volume and PSA density, as determined by the formula, total PSA/transrectal ultrasound volume. RESULTS: The cancer detection rate in the 6 and 12 core groups was almost identical (26% and 27%, p = 0.9). There was no significant difference in cancer detection in the 2 trial arms with respect to subject race, biopsy history, digital rectal examination findings, total PSA, transrectal ultrasound volume or PSA density. However, our study did not have the statistical power to rule out small differences. CONCLUSIONS: The overall cancer detection rate is not materially increased by 12 core, peripheral zone biopsy in men in whom prostate cancer was mainly detected by screening.

Aged↗
PubMed2001

A study of breast cancers detected in the incident round of the UK NHS Breast Screening Programme: the importance of early detection and treatment of ductal carcinoma in situ.

One hundred and seventy eight cancers detected on incident round screening in the UK National Health Service Breast Screening Programme were reviewed. Critical review of the immediately preceding screening films (from 3 years previously) found abnormalities at the site of the subsequently detected cancer in 93 cases (52%). Forty-eight of these (27% of the total) had microcalcification as the sole abnormality. All of these 48 women had invasive ductal carcinoma and/or ductal carcinoma in situ (DCIS) (including four cases in which DCIS was associated with another type of primary invasive breast cancer). The finding of microcalcification on the previous mammograms at the site of a subsequently detected cancer was a strong predictor for the presence of DCIS (with or without associated invasive disease) (P<0.0001). Of the women with invasive ductal carcinoma, those with microcalcification on previous films were significantly more likely to have intermediate or high grade (grade 2 or 3) tumours than those women without microcalcification on previous films (P=0.0015). Previous films were also read blind by two independent experienced breast radiologists. Cancers were correctly identified by one or both readers in 39 cases. However, 35 of the remaining 139 cases showed microcalcification which was not detected or considered significant by the readers. If only these 139 'true negative' screens are analysed, similar associations are seen between microcalcification on previous films and subsequent finding of DCIS (P=0.03) and between microcalcification on previous films and high grade invasive ductal carcinomas (P=0.015). These findings provide support for the hypothesis that microcalcification seen on previous screening films at the site of a subsequently detected invasive ductal carcinoma represents ductal carcinoma in situ. In this series, 19 of 82 women (23%) with invasive ductal carcinoma in the 'true negative' screen group had microcalcification suggestive of DCIS on mammograms taken, on average, 3 years previously. Significant microcalcification is often overlooked using current detection criteria. Early detection and treatment of DCIS is essential in order to prevent the development of aggressive invasive disease. Revision of the NHSBSP targets for DCIS detection is recommended.

Journal Article↗
PubMed1993

Prospective trial evaluating immunocytochemical-based sputum techniques for early lung cancer detection: assays for promotion factors in the bronchial lavage.

To confirm the results of a previous report on the use of monoclonal antibodies in immunocytochemical assays of sputums for the early detection of lung cancer, we designed a new prospective trial in an independent clinical trial population. Since well-characterized Stage I resected non-small cell lung cancer patients have a low rate of tumor relapse and a high (1-3%/year) chance of developing a second primary lung cancer, they comprise a very favorable group for conducting an early lung cancer detection trial. The rate of new lung cancer is about 10-fold in excess of a standard "high" risk population of smokers. To optimize the chance for a favorable outcome, all of the technical components for the trial have been systematically evaluated to ensure that optimal procedures are employed. For example, automated immunostaining of the sputum specimens will be performed. Bronchial lavages will be analyzed in a subset of the trial participants to define additional targets for early lung cancer detection. Two markers will be quantitated, including gastrin releasing peptide and peptidyl glycine alpha-amidating monooxygenase activity. These two markers assess the epithelium's capacity to produce growth factors which may be central to the biology of tumor promotion. Since these assays have not been performed in this context before, we attempted to optimize the specimen handling to permit the receipt of the material from a range of collaborating clinical sites in a condition that permits accurate quantitation of these two biomarkers. Efforts to standardize the assay endpoint stimulated the development of computer-assisted methods of immunocytochemical analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗