Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Sun Yat-sen University

Status: Unknown

Conditions: Colorectal Adenomatous Polyp; Screening; Colorectal Cancer

Treatments: Diagnostic Test: Stool-based SDC2 DNA methylation test; Diagnostic Test: Fecal immunochemical test

Study type: Interventional

Funder types: Other

Identifiers

NCT04221854

CCRCSIP

Details and patient eligibility

About

The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Full description

A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months.

Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is average risk for development of colorectal cancer.
2. Subject is able and willing to undergo a screening colonoscopy within six months of enrollment.
3. Subject is 45 to 80 years of age inclusive.
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
5. Subject is able and willing to provide stool samples according to written instructions provided to them.

Exclusion criteria

1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
2. Subject has a history of colorectal cancer or adenoma.
3. Subject has a history of other digestive tract cancer.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50,000 participants in 2 patient groups

Stool-based SDC2 DNA methylation test group

Experimental group

Description:

Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.

Treatment:

Diagnostic Test: Stool-based SDC2 DNA methylation test

Fecal immunochemical test group

Active Comparator group

Description:

Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.

Treatment:

Diagnostic Test: Fecal immunochemical test