ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Impact of preanalytic factors on the design and application of integral biomarkers for directing patient therapy.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed.
- Challenges in the Metabolomics-Based Biomarker Validation Pipeline.Metabolites · 2024Review
- The Impact of Pre-analytical Quality Initiatives on Cholangiocarcinoma Diagnostics in Thailand.Frontiers in public health · 2022Article
- Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.Clinical pharmacology and therapeutics · 2020Article
- Histomorphological and Molecular Assessments of the Fixation Times Comparing Formalin and Ethanol-Based Fixatives.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2018Article
- Translating pharmacodynamic biomarkers from bench to bedside: analytical validation and fit-for-purpose studies to qualify multiplex immunofluorescent assays for use on clinical core biopsy specimens.Seminars in oncology · 2016Review
- A Buffered Alcohol-Based Fixative for Histomorphologic and Molecular Applications.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2016Article
- Epidermal growth factor receptor immunohistochemistry: new opportunities in metastatic colorectal cancer.Journal of translational medicine · 2015Review
- Critical roles of specimen type and temperature before and during fixation in the detection of phosphoproteins in breast cancer tissues.Laboratory investigation; a journal of technical methods and pathology · 2015Article
- Molecular oncology testing in resource-limited settings.The Journal of molecular diagnostics : JMD · 2014Review
- Improving the state of the science of immunohistochemistry: the Histochemical Society's standards of practice.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2014Article
- Profiling of phospho-AKT, phospho-mTOR, phospho-MAPK and EGFR in non-small cell lung cancer.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2014Article
- Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.Virchows Archiv : an international journal of pathology · 2014Review
- Biomarkers in precision therapy in colorectal cancer.Gastroenterology report · 2013Article
- Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Development and use of integral assays in clinical trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Molecular assays have been routinely applied to improve diagnosis for the last 25 years. Assays that guide therapy have a similar history; however, their evolution has lacked the focus on analytic integrity that is required for the molecularly targeted therapies of today. New molecularly targeted agents require assays of greater precision/quantitation to predict the likelihood of response, i.e., to identify patients whose tumors will respond, while at the same time excluding and protecting those patients whose tumors will not respond or in whom treatment will cause unacceptable toxicity. The handling of tissue has followed a fit-for-purpose approach focused on appropriateness for diagnostic needs, which is less rigorous than the demands of new molecular assays that interrogate DNA, RNA, and proteins in a quantitative, multiplex manner. There is a new appreciation of the importance and fragility of tissue specimens as the source of analytes to direct therapy. By applying a total test paradigm and defining and measuring sources of variability in specimens, we can develop a set of specifications that can be incorporated into the clinical-care environment to ensure that a specimen is appropriate for analysis and will return a true result.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.