ArticleJMIR research protocols2016
Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on Blood Biomarkers.
Article in JMIR research protocols, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04302363 (Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer), which is not on this map. Cited by 10 papers.
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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.
Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer: a Study Protocol for Colorectal Neoplasms Screening
Who cites it
10 citing papers in PubMed, 23 citations in OpenAlex.
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- DNA methylation markers for sensitive detection of circulating tumor DNA in patients with gastroesophageal cancers.ESMO gastrointestinal oncology · 2024Article
- Ultrasensitive plasma-based monitoring of tumor burden using machine-learning-guided signal enrichment.Nature medicine · 2024Article
- A Checklist for Reproducible Computational Analysis in Clinical Metabolomics Research.Metabolites · 2022Review
- Age-stratified reference intervals unlock the clinical potential of circulating cell-free DNA as a biomarker of poor outcome for healthy individuals and patients with colorectal cancer.International journal of cancer · 2021Article
- Biomarkers for Early Detection of Colorectal Cancer: The Early Detection Research Network, a Framework for Clinical Translation.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2020Article
- Triage May Improve Selection to Colonoscopy and Reduce the Number of Unnecessary Colonoscopies.Cancers · 2020Article
- Novel DNA methylation biomarkers show high sensitivity and specificity for blood-based detection of colorectal cancer-a clinical biomarker discovery and validation study.Clinical epigenetics · 2019Article
- Clean Colorectum at Diagnostic Colonoscopy: Subsequent Detection of Extracolonic Malignancies by Plasma Protein Biomarkers?Biomarkers in cancer · 2018Article
Corrections and comments
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Authors and funding
18 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPrograms for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements.
objectivesThe protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT.
methodsIn Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms.
resultsWe anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination.
conclusionsThe purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.
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