NCT06772844

DYNAMICS-LYNCH：DNA Methylation Analysis in Stool for Screening of Lynch Syndrome-Associated Colorectal Cancer

Not yet recruiting Last updated 15 January 2025

What this trial tests

trial testing fecal DNA methylation testing in Colorectal Cancer Screening in 400 participants. Not yet recruiting.

Timeline

10 January 2025

Primary endpoint
30 June 2028

31 December 2028

Quick facts

Lead sponsor	Sun Yat-sen University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	400
Start date	10 January 2025
Primary completion	30 June 2028
Estimated completion	31 December 2028

Drugs / interventions tested

• fecal DNA methylation testing

Conditions studied

• Colorectal Cancer Screening — all drugs for Colorectal Cancer Screening →
• Lynch Syndrome — all drugs for Lynch Syndrome →

Sponsor

Sun Yat-sen University

Who can join

Eligibility, any sex, with Colorectal Cancer Screening or Lynch Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colorectal cancer (CRC) has high incidence and mortality rates globally. Over 1 million new cases are diagnosed annually, and about 600,000 people die from the disease each year. In China, CRC ranks third in incidence and fifth in mortality. Its rates are rising due to lifestyle changes and an aging population.

Around 30% of CRC cases have a hereditary component, including familial adenomatous polyposis (FAP) and Lynch syndrome. Lynch syndrome, or hereditary non-polyposis colorectal cancer (HNPCC), accounts for 3%-5% of CRC cases. Early diagnosis, screening, and prophylactic surgery can reduce CRC mortality by 7%-42%, and mortality from endometrial and ovarian cancers by 1%-6%. Intensive screening is essential for Lynch syndrome patients, who are at high risk for CRC.

Due to the lack of early symptoms, many CRC cases are diagnosed in later stages, causing financial strain on patients, families, and society. Screening is an effective tool in reducing CRC-related mortality by more than 50%. In developed countries such as the U.S., U.K., and Japan, CRC screening is integrated into public health programs, emphasizing its role in prevention.

In China, CRC screening mainly involves the fecal occult blood test followed by colonoscopy, but this method faces challenges. First, the fecal occult blood test lacks sufficient sensitivity, leading to underdiagnosis. Second, colonoscopy is invasive with low patient acceptance. It also requires specialized facilities, advanced equipment, and skilled endoscopists, limiting its accessibility. Given China's large population and limited healthcare resources, universal colonoscopy screening is challenging, resulting in low screening rates.

To address these challenges, we propose replacing part of colonoscopy screening with DNA methylation testing of fecal samples. Self-sampling methylation screening could ease the strain on healthcare resources and improve patient compliance. By combining methylation screening with colonoscopy, we aim to reduce colonoscopy frequency and enhance overall compliance.

This study will include three rounds of methylation screening with colonoscopy as the control, involving 400 Lynch syndrome patients. The goal is to develop new screening criteria for this high-risk group, reduce colonoscopy frequency, and ultimately lower CRC incidence in Lynch syndrome patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.