Catch the cancer; towards a cfDNA-based test for colorectal cancer screening

Completed

• Conditions: colorectal cancer; colorectal carcinoma; 10018018; 10017990; 10017991

• Registration Number: NL-OMON48193
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Individuals participating in the Dutch national colorectal cancer screening program who:
- Have a positive FIT (fecal immunohistochemical test), prior to sequential colonoscopy (performed in the Erasmus MC);
- Grant informed consent to participate in this study;;Lynch Syndrome carriers under surveillance of gastroenterologists in the Erasmus MC, who:
- Have proven Lynch syndrome (DNA mismatch repair mutation);
- Are >=18 years;
- Grant informed consent to participate in this study.

Exclusion Criteria

Individuals participating in the Dutch national colorectal cancer screening program who:
- Are known to be carrier of a genetic predisposition for colorectal cancer (for example Familial Adenomatous Polyposis or MUTYH Associated Polyposis);
- Have a negative FIT;
- Have a positive FIT with sequential colonoscopy already performed;
- Are unwilling to undergo colonoscopy or receive unexpected, but relevant and actionable findings;
- Underwent a failed colonoscopy;;Lynch Syndrome carriers who:
- Are unwilling to undergo colonoscopy or receive unexpected, but relevant and actionable findings;
- are <18 years;
- underwent a failed colonoscopy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The agreement between cfDNA profiles and DNA profiles of corresponding lesions<br /><br>found during regular colonoscopy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> The extent of psychological burden caused by this screening tool.</p><br>