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PubMed1999

Biomarkers of bone turnover and bone mineral density in hyperprolactinemic amenorrheic women.

We tested the hypothesis that biomarkers of bone resorption are increased in hyperprolactinemic amenorrheic patients with estrogen (E) deficiency, augmenting the possible risk of developing osteoporosis. Fifty hyperprolactinemic patients with amenorrhea of more than 12 months and with low serum E2, as well as 30 healthy fertile women (controls), matched for age and body mass index, participated in this study. Bromocriptine was administered orally to hyperprolactinemic patients and blood and urine samples were collected before and 12 weeks after treatment. Serum osteocalcin (OC) and bone-specific alkaline phosphatase (B-ALP), reflecting bone formation, and urinary deoxypridinoline (D-Pyr) and N-telopeptide of type 1 collagen (NTX) excretion, reflecting bone resorption, were measured using direct immunoassays. Hyperprolactinemic patients had higher (p < 0.0005) levels of all the biomarkers compared to control values: (OC, 22+/-1.2 [SE] vs. 14+/-.99 ng/ml (+57 %); B-ALP, 14.2+/-0.7 vs. 7.5+/-0.8 ng/ml (+89 %); D-Pyr, 8.8+/-0.6 vs. 3.2+/-0.3 nmol/mmol creatinine (+175%) and NTX, 65+/-5.1 vs. 25+/-3.2 nmol bone collagen equivalent (BCE)/mmol creatinine (+160%)). These results were associated with significantly decreased lumbar spine bone mineral density (LS-BMD), measured by dual energy X-ray absorptiometry (DEXA). Treatment of hyperprolactinemia with bromocriptine restored normal values of bone formation and resorption markers. In conclusion, hyperprolactinemia with estrogen deficiency exhibits a significant increase of bone resorption which is associated with a significant decrease of LS-BMD. These changes may subject the patient to the possible risk of developing osteoporosis.

Adult↗
PubMed2026

Cost-Effectiveness and the Economics of Genomic Testing and Molecularly Matched Therapies.

Cost-effectiveness analysis of precision oncology can help guide value-driven care. Next-generation sequencing is increasingly cost-efficient over single gene testing because diagnostic algorithms require multiple individual gene tests to determine biomarker status. Matched targeted therapy is often not cost-effective due to the high cost associated with drug treatment. However, genomic profiling can promote cost-effective care by identifying patients who are unlikely to benefit from therapy. Additional applications of genomic profiling such as universal testing for hereditary cancer syndromes and germline testing in patients with cancer may represent cost-effective approaches compared with traditional history-based diagnostic methods.

Humans↗
PubMed2026

Comparison of classic statistical methods and machine learning approaches to classify readiness.

MOTIVATION: Predicting physical and cognitive readiness in warfighters is critical for mission success. These predictions can be improved by identifying key biomarkers using multiple omics modalities. The MASTR-E study conducted by McKetney and colleagues is one of the most comprehensive multi-omics studies of saliva samples collected from warfighters, which also applied classic linear statistical (CLS) techniques to discover key biomarkers of readiness. Aligning with McKetney et al.'s assumptions, we operationalize readiness as a binary proxy, where pre-mission samples are labeled as "ready" to reflect a rested, unstressed physiological baseline, while post-mission samples are labeled "not ready" to reflect cumulative physical and cognitive load from the mission. As such, readiness here is not a direct biological or physiological construct, but an inferred state likely dominated by stress-related physiological changes. This assumption and definition is discussed further in the Introduction and Limitations sections. Here, we apply machine learning (ML) analyses to better assess generalizability, consider hidden interactions, and identify nonlinear patterns in the data. We investigated whether ML approaches could predict readiness and identify relevant biomarkers. ML models were trained on proteomics-only or metabolomics-only datasets to classify participants as ready or not ready and important model features were considered as putative biomarkers. Training and testing datasets were curated for two objectives: (i) recognize biomolecular signatures indicative of readiness within the same donor and (ii) assess generalizability across warfighters by withholding donors for testing. RESULTS: Proteomics-based models achieved AUCs of 0.907&#x2009;&#xb1;&#x2009;0.034 and 0.860&#x2009;&#xb1;&#x2009;0.063 for Objectives 1 and 2, respectively. Metabolomics-based models achieved Objective 1 AUC of 0.994&#x2009;&#xb1;&#x2009;0.007 and Objective 2 AUC of 0.993&#x2009;&#xb1;&#x2009;0.010. Comparative analysis with existing literature validates the model's feature importances, but the identified putative biomarkers significantly differ from those discovered through CLS analyses, as only one ML-identified biomarker overlapping with those identified through CLS methods. We show that these ML models and identified features are more robust to noise and generalizable across participants than those identified using CLS methods. AVAILABILITY: The analysis pipelines are provided as Jupyter notebooks, including all code and documentation, and are available publicly on GitHub at {https://github.com/netrias/ReadinessClassification}.

Machine Learning↗
PubMed2006

Predictors of conversion to dementia of probable Alzheimer type in patients with mild cognitive impairment.

BACKGROUND: Mild Cognitive Impairment is a common condition defined as transitional state between normality and dementia of Alzheimer type. Clinically is characterized by subjective and objective memory loss beyond the expected for age and educational level, although a broad range of cognitive inefficiencies may appear, with preservation of daily living activities. Approximately half the patients convert to dementia within 3 years. Since no all patients convert to dementia it is essential to find reliable predictors so as to start the appropriate treatment as soon as possible. METHOD: Extensive Medline-based search for articles dealing with predictors of conversion to dementia in Mild Cognitive Impairment (MCI). RESULTS: There is a substantial body of literature dealing with predictors of dementia in patients with MCI. These predictors range from a simple delayed recall task on Mini-Mental to sophisticated radiological techniques and CSF biomarkers. Comprehensive neuropsychological tests rarely surpass 70% sensitivity and specificity. The presence of the APOE epsilon 4 allele has been associated with increased risk of conversion but the sensitivity is quite low. CSF biochemical markers are being developed with encouraging results. beta-amyloid 42 protein is usually lower in converters than in people with stable cognitive status and tau protein is higher. The sensitivity is substantial but specificity is so far low. An epitope of tau protein (P231) looks more specific of Alzheimer's disease and therefore a promising biomarker. In the blood, high beta-amyloid protein levels indicate risk of conversion but only a few studies have been published. Hippocampal or entorhinal atrophy on MRI is one of the most used radiological markers of conversion but quantification of atrophy is not simple as it is subject to artifacts and anatomic variations. Proton Magnetic Resonance Spectroscopy (MRS) and Positron Emission Tomography (PET) are emerging as the most promising predictive tools. The highest degree of accuracy (>90%) has been achieved by means of PET plus either memory performance or APOE4 genotype. However, the samples of the published studies are mostly small, and these instruments are not widely available. CONCLUSIONS: There is no enough evidence to recommend specific techniques for predictions. Until an accurate marker is developed, a combined use of cognitive tests, APOE genotype, and a neuroradiological technique is probably the best option for prediction purposes depending on availability and experience.

Alzheimer Disease↗
PubMed2026

Mechanism-Driven Diagnostic Development: A Specimen-Aware Framework Illustrated by Colorectal Cancer and Solid Tumours.

Translational oncology has moved rapidly from histopathology and single-analyte biomarkers toward multi-dimensional molecular profiling. Yet many clinically deployed tests still use reductionist biomarker strategies that under-represent cancer complexity. This review examines whether a mechanistic, multi-layered, and specimen-aware approach can improve cancer detection, classification, prognosis, minimal residual disease (MRD) assessment, and therapeutic selection. Evidence across solid tumours shows that genomic alterations alone incompletely explain tumour state, metastatic behaviour, immune evasion, or therapeutic vulnerability. Integrated genome and transcriptome analyses, proteogenomics, single-cell atlases, fragmentomic, methylation based cell-free DNA assays, metabolomics and microbiome assessments reveal clinically relevant biology that single modality tests cannot determine. Minimally invasive collected specimens can extend access to screening, diagnosis and longitudinal monitoring, but the choice of specimen should be matched to disease biology and analytes that represent mechanisms of oncogenesis. However, translation remains constrained by pre-analytical variability, contamination, differences in tumour shedding behaviour, clonal haematopoiesis, translation of generated models, incomplete external validation and uncertain downstream clinical utility for emerging platforms. This review provides a commentary on the future of cancer diagnostics, the considerations and barriers to clinical translation, the relationship between utility and dimensionality of biomarkers assessed and the emerging rationale towards mechanistically grounded integrated models.

biomarkers↗
PubMed2006

Do biomarkers of stress mediate the relation between socioeconomic status and health?

OBJECTIVES: To test the relation between socioeconomic status (SES) and biomarkers of chronic stress, including basal cortisol, and to test whether these biomarkers account for the relation between SES and health outcomes. DESIGN: Cross sectional study using data from the 2000 social and environmental biomarkers of aging study (SEBAS). SETTING: Taiwan. PARTICIPANTS: Nationally representative sample of 972 men and women aged 54 and older. MAIN OUTCOME MEASURES: Highest risk quartiles for 13 biomarkers representing functioning of the neuroendocrine system, immune/inflammatory systems, and the cardiovascular system: cortisol, adrenaline (epinephrine), noradrenaline (norepinephrine), serum dihydroepiandrosterone sulphate (DHEA-S), insulin-like growth factor 1 (IGF1), interleukin 6 (IL6), albumin, systolic blood pressure, diastolic blood pressure, waist-hip ratio, total cholesterol-HDL ratio, HDL cholesterol, and glycosylated haemoglobin; self reported health status (1-5) and self reported mobility difficulties (0-6). RESULTS: Lower SES men have greater odds of falling into the highest risk quartile for only 2 of 13 biomarkers, and show a lower risk for 3 of the 13 biomarkers, with no association between SES and cortisol. Lower SES women have a higher risk for many of the cardiovascular risk factors, but a lower risk for increased basal readings of adrenaline, noradrenaline, and cortisol. Inclusion of all 13 biological markers does not explain the relation between SES and health outcomes in the sample. CONCLUSIONS: These data do not support the hypothesis that chronic stress, via sustained activation of stress related autonomic and neuroendocrine responses, is an important mediator in the relation between SES and health outcomes. Most notably, lower SES is not associated with higher basal levels of cortisol in either men or women. These results place an increased burden of proof on researchers who assert that psychosocial stress is an important pathway linking SES and health.

Aged↗
PubMed2006

Monitoring of asthma control in children.

PURPOSE OF REVIEW: The focus in managing asthma has undergone a paradigm shift from the concept of assessing severity to assessing control. The recent Practice Parameter on attaining optimal asthma control highlights the need to titrate the step-care management of asthma to the level of control assessed at each clinic encounter. RECENT FINDINGS: Recent advances in the monitoring of asthma control in children include the use of questionnaires such as the Childhood Asthma Control Test, use of biomarkers such as fractional concentration of exhaled nitric oxide, sophisticated hand-held electronic monitoring of lung function such as peak flow and forced expiratory volume, indicators of lung growth and bronchial hyper-responsiveness such as post-bronchodilator forced expiratory volume, outcomes-utilization data, markers of atopy, and electronic measures of adherence. SUMMARY: Three recent proof-of-concept studies in adults have demonstrated the relevance of criteria other than guidelines-recommended asthma symptoms and pulmonary function tests. These studies used airway hyper-responsiveness, sputum eosinophilia, and fraction of exhaled nitric oxide as indices to facilitate fine-tuning of asthma control and use of controller-inhaled steroids. The next logical step would be to determine the applicability of these and other measures to children in both research and clinical settings.

Adolescent↗
PubMed2003

Biomarkers in fish from Prince William Sound and the Gulf of Alaska: 1999-2000.

To test the hypothesis that biomarker levels in fish collected at Prince William Sound (PWS) sites impacted by the 1989 Exxon Valdez oil spill were higher than those collected at unimpacted sites, a 1999-2000 study collected five fish species and associated benthic sediments from 21 sites in PWS and the eastern Gulf of Alaska (GOA). PWS sites were divided in three oiling categories based upon 1989 shoreline assessments: nonspill path (NSP), spill path oiled (SPO), and spill path not oiled (SPNO). Rockfish (N = 177), rock sole (N = 30), and kelp greenling (N = 49) were collected at near-shore locations (approximately 50-500 m from shore); Pacific halibut (N = 131) and Pacific cod (N = 81) were collected further offshore (approximately 500-7000 m). Fish were assayed for bile fluorescent aromatic contaminants (FAC) and cytochrome P4501A (CYP1A) levels measured as liver ethoxyresorufin O-deethylase (EROD) activity and by immunohistochemistry (IHC) of various tissues. For all species studied at all sites, bile FAC concentrations and CYP1A levels were low and in the same range for fish collected at PWS SPO and SPNO sites relative to NSP sites in PWS and the GOA. Consequently, the hypothesis is rejected for the species studied. The bile FAC results further indicate a pervasive exposure of fish at all sites, including those in the GOA far removed from the effects of the spill, to low levels of polycyclic aromatic hydrocarbons. Analysis of the benthic sediments indicates that the probable sources of this exposure are petrogenic hydrocarbons derived from natural oil seeps and eroding sedimentary rocks in the eastern GOA.

Accidents↗
PubMed2005

Cervical chromosome 9 polysomy: validation and use as a surrogate endpoint biomarker in a 4-HPR chemoprevention trial.

BACKGROUND: Several genetic alterations have been described in cervical cancers including: human papillomavirus (HPV) E6 and E7 oncoproteins, subtle sequence changes, alterations in chromosome number, chromosome translocations, and gene amplifications. This report focuses on establishing chromosome 9 polysomy as a cervical biomarker of chromosome instability and using it in a chemoprevention trial. Chromosomal instability is a feature of most human cancers and is probably an early event in the process. METHODS: We used 37 cervical cone specimens to validate chromosome 9 polysomy as a biomarker and then tested its modulation in a randomized clinical trial of 4-hydroxyphenylretinamide (4-HPR) in 39 patients with three blinded histopathologic reviews. No confounders were identified. In the present study, immunohistocytochemical analysis of Chromosome 9 polysomy was carried out and quantitatively measured. RESULTS: The Cell Index, the ratio of the number of total chromosome 9 copies to the total number of ells, increases significantly in archival samples as the cervix changes from normal to CIN to invasive cancer. In the chemoprevention trial, chromosome 9 polysomy was used as a biomarker and supported the histological analysis showing that 4-HPR impaired the natural regression response. CONCLUSIONS: Chromosome 9 polysomy appears to be a marker of genetic instability that can be used in chemoprevention trials as a surrogate endpoint biomarker. In this randomized trial of 4-HPR, the chromosome 9 polysomy measurements supported the clinical histopathologic reading in a quantitative manner suggesting that 4-HPR at 200 mg/day may have been inhibiting the regression seen in the placebo arm by inducing genetic instability.

Aneuploidy↗
PubMed2006

Translational proteomics: developing a predictive capacity -- a review.

Over the past decade, proteomics has undergone a rapid development and radiation, diversifying across the biochemical landscape. While no single technique yet delivers complete proteomic coverage, application-specific adaptations afford significant opportunity for discovery and the development of predictive capacity (e.g. surrogate biomarker and clinical diagnostics). Targeted proteomic approaches, protein profiling strategies using affinity capture mass spectrometry and solution array represent realistic opportunities to deliver predictive capacity. The aim of this review is to provide an overview of proteomic technologies and how the outcomes delivered by such platforms may be translated into applications of predictive utility in clinical and basic science. In particular, recent applications in protein/peptide profiling (solid-phase affinity capture mass spectrometry and the targeted approach of antibody arrays) and the opportunities they afford researchers within the discipline of reproductive biology to develop new diagnostic and prognostic tests and surrogate biomarkers to improve the delivery of women's health care are considered.

Animals↗
PubMedDate not supplied

Cerebrospinal fluid biomarkers in primary headache disorders.

OBJECTIVE: The object of this review is to examine the published literature for cerebrospinal fluid laboratory measures of primary headache disorders to identify biomarkers and provide recommendations for future biomarker discovery. BACKGROUND: Biomarkers may distinguish deviation from a normal state, provide insight into mechanisms of pathophysiology, quantify the degree of change, discriminate what may be clinically overlapping disorders, and allow monitoring and/or selection of specific treatment. High-throughput, discovery technologies fuel the ability to reveal more biomarkers than past hypothesis-driven studies. DESIGN OR METHODS: Publications were identified in PubMed, ISI web of knowledge (both Web of Science and BIOSYS), and SciFinder, using the key words for cerebrospinal fluid (CSF) and migraine, headache, or biomarkers. Additional references were sought from the papers identified in these searches. Data were assessed relating to all primary headache types for clinical and scientific methods and results. RESULTS: Fifty-five out of 82 biomarkers were found from 55 publications, though none have been validated for clinical utility. Data for site (ventricular, cervical, lumbar) and timing of CSF collection, headache state, and diagnostic description were patchy, and controls were often poorly defined. Most routinely performed CSF measurements were within normal limits. Most levels of pain-related molecules were reduced, and concentrations of most neurotransmitters, neuropeptides, proteins, and small molecules were increased. Though few studies assessed the specificity of biomarkers for primary headaches, it is clear that there are differences in CSF biomarkers between migraine, cluster headache, tension-type headache, and trigeminal neuralgia. CONCLUSIONS: The high proportion (67%) of biomarkers identified from laboratory measures tested thus far predicts that many more biomarkers will be identified for primary headaches when more candidates are evaluated. In order to discover and evaluate more biomarkers, especially those that may have clinical application for headache management, 3 recommendations are encouraged: prospective design of care-independent studies; evaluation of more clinical variables; and evaluation of substantially more candidates by using discovery-based research methods. Outlines of approaches to pursue these aims are proposed.

Biomarkers↗
PubMed2004

The relationship between lysosomal biomarker and organismal responses in an acute toxicity test with Eisenia Fetida (Oligochaeta) exposed to the fungicide copper oxychloride.

The LC50 of copper oxychloride for Eisenia fetida was determined, and its effects on biomass change and lysosomal damage using neutral red retention times (NRRT) of coelomocytes were measured. The aim was to establish whether a lysosomal subcellular response, measured as NRRT, could be linked to the LC50 and biomass changes. Further, we attempted to establish the ecological relevance of the LC50 by comparing it to studies previously carried out on the effects of copper oxychloride on field earthworm populations. The experiment was conducted over a period of 28 days, during which the earthworms were exposed to different concentrations of copper oxychloride in artificial soil. The calculated LC50 was 883 microg g(-1) for copper oxychloride and 519 microg g(-1) for copper. Results indicated that changes in coelomocyte membrane stability manifested earlier than effects on biomass. Since the NRRT assay was very sensitive and generated an early response before changes in biomass or mortality could be measured, it may have predictive value and may contribute information during acute toxicity tests, which could be of greater ecological relevance than mortality data alone.

Animals↗
PubMed2026

Identifying gene expression signatures for risk stratification of postoperative adjuvant chemotherapy in colorectal cancer.

Clinical risk stratification for postoperative recurrence in patients with pathological stage II (pStage II) colorectal cancer (CRC) is essential for guiding the use of postoperative adjuvant chemotherapy (ACT). In this study, we identified novel prognostic gene expression biomarkers in patients with pStage II CRC and developed a new risk stratification framework for ACT decision-making. First, genome-wide biomarker discovery was conducted to identify prognostic gene expression biomarkers associated with recurrence risk in pStage II CRC. This analysis identified 10 differentially expressed genes as potential biomarkers for recurrence. The efficacy of these biomarkers was then tested using 188 clinical surgical specimens obtained from patients with pStage II CRC. A predictive panel was developed using qRT-PCR and used to assess 93 clinical specimens with an area under the curve (AUC) of 0.82, and its performance was further validated in an independent cohort (n&#x2009;=&#x2009;95). By incorporating key clinicopathological features, a Gene expression-based Prediction of Recurrence in pStage II CRC (GPRSC) signature was developed, which robustly predicted postoperative recurrence (AUC: 0.80). Finally, combining the GPRSC signature, microsatellite instability status, and conventional criteria, we developed a novel risk stratification system for postoperative ACT decision-making in pStage II CRC. Overall, we identified novel gene expression biomarkers and developed a prognostic signature that informs clinical decision-making regarding postoperative ACT in patients with pStage II CRC.

Humans↗
PubMed2006

Extent of corneal injury as a biomarker for hazard assessment and the development of alternative models to the Draize rabbit eye test.

We have characterized 22 ocular irritants differing in type (surfactants, acid, alkali, bleaches, alcohol, aldehyde, acetone) and severity (slight to severe) by using the low-volume rabbit eye test. Ocular irritation was evaluated by 1) light microscopy to assess pathological changes, 2) in vivo confocal microscopy (CM) to quantify 4-dimensionally (x, y, z, and t) initial corneal injury and later responses in the same eye, and 3) laser scanning CM to quantify initial cell death. These studies revealed that regardless of the processes leading to injury, slight irritants injure the corneal epithelium, mild irritants injure the corneal epithelium and the superficial stroma, and moderate/severe irritants injure the epithelium, deep stroma, and at times the corneal endothelium. Furthermore, extent of initial corneal injury was shown to predict subsequent responses and final outcomes. These findings suggest that extent of corneal injury may be used as a basis for the development of alternative ocular irritation tests. To test the validity of this approach, we have used an ex vivo, rabbit cornea culture model to measure extent of corneal injury following exposure to ocular irritants. Data indicate that the extent of ex vivo corneal injury significantly correlate with the extent of initial injury measured previously in live animals. Overall, these findings indicate that extent of initial corneal injury can be used as a new "gold standard" for the continued refinement and ultimate replacement of the Draize rabbit eye Ocular Irritation Test.

Animal Testing Alternatives↗
PubMed2002

[Risk estimation in Barrett's esophagus: biomolecular marker and histopathologic classification].

The diagnosis of Barrett's esophagus and the different degrees of intraepithelial neoplasia appear to be demanding in several aspects. Current data on genetic alterations involved in the carcinogenesis of Barrett's esophagus are discussed. Several new biomarkers are being tested to help better to determine the risk of cancer development. However, a few immunohistochemical markers have emerged which could be helpful for the differential diagnosis of low- and high-grade intraepithelial neoplasia. Markers which could predict the progression of premalignant Barrett's epithelium to carcinoma are still to be established. At present, the "gold standard" for classifying the malignant potential in Barrett's esophagus is the degree of intraepithelial neoplasia found on standard biopsy protocols.

Barrett Esophagus↗