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

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.

Conditions

• Colorectal Cancer
• Colorectal Adenomatous Polyp
• Screening

Interventions

DIAGNOSTIC_TEST

Stool-based SDC2 DNA methylation test

Stool-based SDC2 DNA methylation test

DIAGNOSTIC_TEST

Fecal immunochemical test

Fecal immunochemical test

Sponsors & Collaborators

• Shanghai Municipal Center for Disease Control and Prevention

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Tianjin Nankai Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Guangzhou Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Sixth Affiliated Hospital, Sun Yat-sen University

  lead OTHER

Principal Investigators

• Kai Gu, MD · Shanghai Municipal Center for Disease Control and Prevention

• Enda Yu, MBBS · Changhai Hospital

• Ximo Wang, MD, PhD · Tianjin Nankai Hospital

• Shan Wang, MD, PhD · Peking University People's Hospital

• Jiahua Leng, MD, PhD · Peking University Cancer Hospital & Institute

• Dong Xu, MD, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Pengzhe Qin, MD · Guangzhou Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-06

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• China

Study Locations