Open AccessProtocol 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
Author(s) -
Louise Rasmussen,
Michael Wilhelmsen,
Ib Jarle Christensen,
Jens Rikardt Andersen,
Lars Nannestad Jørgensen,
Morten Rasmussen,
Jakob Hendel,
Mogens Rørbæk Madsen,
Jesper Vilandt,
Thore Hillig,
Michael Klærke,
Anna-Marie Bloch Münster,
Lars Maagaard Andersen,
Berit Andersen,
Nete Hornung,
Erland J. Erlandsen,
Ali Qusay Khalid,
Hans Jørgen Nielsen
Publication year - 2016
Publication title -
jmir research protocols
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.378
H-Index - 9
ISSN - 1929-0748
DOI - 10.2196/resprot.6346
Subject(s) - colonoscopy , colorectal cancer , population , medicine , protocol (science) , psychological intervention , oncology , cancer , pathology , alternative medicine , environmental health , psychiatry
Background Programs 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. Objectives The protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT. Methods In 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. Results We 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. Conclusions The 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.