cfDNA can be used to develop a reliable bloodtest for identification of advanced adenoma and colorectal cancer
ID
Source
Brief title
Health condition
Lynch syndrome, colorectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The agreement between cfDNA profiles and DNA profiles of corresponding lesions (advanced adenomas, CRC)
Secondary outcome
The psychological impact of this cfDNA-based blood test.
Background summary
Introduction of the national screening program for colorectal cancer (CRC) has improved the prevention and early detection of this disease. The screening consists of a fecal immunohistochemical test for hemoglobin (FIT), which is followed by a colonoscopy if positive. Nevertheless, the FIT’s sensitivity and specificity are still low, leading to an unnecessary colonoscopy in half of the FIT positive individuals. Patients with Lynch Syndrome (LS) are advised to undergo surveillance colonoscopies every two years. However, a colonoscopy is burdensome, and it doesn’t provide detection of extra colonic cancers associated with LS. A reliable, more efficient test is needed to identify individuals with adenomas and/or early carcinomas, both sporadic as LS-associated. For this purpose, a blood test based on cell free DNA (cfDNA) might have potential. This test is currently used to monitor tumor activity in cancer patients. Therefore, we hypothesize that cfDNA analysis can also be used as a non-invasive screening test for precursor lesions and/or early cancer. Thus, our primary objective is to develop a cfDNA based screening/surveillance tool for colorectal adenoma and cancer, both in the setting of the national CRC screening program and in the surveillance of LS carriers. Secondarily, we aim to evaluate the psychological impact of this new way of cancer screening for patients (especially regarding incidental findings).
Study objective
cfDNA can be used to develop a reliable bloodtest for identification of advanced adenoma and colorectal cancer
Study design
Inclusion of participants: starting June 2020
Intervention
Drawing blood, questionnaires
Inclusion criteria
Lynch syndrome carriers (of at least 18 years of age) being under surveillance in our centre that granted informed consent to participate in our study OR participants from the national CRC screening program with a positive FIT that granted informed consent to participate in our study.
Exclusion criteria
Individuals participating in the Dutch national CRC screening program who are known to be carrier of a genetic predisposition for CRC (for example Familial Adenomatous Polyposis or MUTYH Associated Polyposis), or have a negative FIT, or have a positive FIT with sequential colonoscopy already performed, or are unwilling to undergo colonoscopy or to receive unexpected, but relevant and actionable findings, or underwent a failed colonoscopy; and LS carriers who are unwilling to undergo colonoscopy or to receive unexpected, but relevant and actionable findings, who are <18 years, who underwent a failed colonoscopy.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8695 |
| CCMO | NL68955.078.19 |
| OMON | NL-OMON48193 |