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

Not Applicable

• Conditions: Screening; Colorectal Cancer; Colorectal Adenomatous Polyp
• Interventions: Diagnostic Test: Stool-based SDC2 DNA methylation test; Diagnostic Test: Fecal immunochemical test

• Registration Number: NCT04221854
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stool-based SDC2 DNA methylation test group	Stool-based SDC2 DNA methylation test	Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.
Fecal immunochemical test group	Fecal immunochemical test	Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.

Primary Outcome Measures

Name	Time	Method
The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods	One year	The stool-based SDC2 DNA methylation test CT values of 38 or less compared to beta-actin considered to be positive. Fecal immunochemical test values of more than 100 ng of hemoglobin per milliliter of buffer were considered as positive. An optical colonoscopy is used as diagnostic method. Lesions will be confirmed by histopathologic examination.

Trial Locations

Locations (8)

The Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Peking University People's Hospital; 🇨🇳 Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China

Guangzhou Center for Disease Control and Prevention; 🇨🇳 Guangzhou, China

Changhai Hospital; 🇨🇳 Shanghai, China

Shanghai Municipal Center for Disease Control and Prevention; 🇨🇳 Shanghai, China

Tianjin Nankai Hospital; 🇨🇳 Tianjin, China