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

Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Colorectal Adenomatous Polyp; Screening
• Intervention / Treatment: Diagnostic test: Stool-based SDC2 DNA methylation test; Diagnostic test: Fecal immunochemical test

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 Type: Interventional
• Enrollment (Anticipated): 50000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping Lan, M.D., Ph.D.; Phone Number: +86-13710316769; Email: lanping@mail.sysu.edu.cn
• Study Contact Backup: Name: Yufeng Chen, MD, PhD; Phone Number: +86-13710555130; Email: chenyf78@mail.sysu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Shan Wang, MD, PhD
    • Principal Investigator: Shan Wang, MD, PhD
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Jiahua Leng, MD, PhD
    • Principal Investigator: Jiahua Leng, MD, PhD
  • Guangzhou, China
    • Recruiting
    • Guangzhou Center for Disease Control and Prevention
    • Contact: Pengzhe Qin, MD
    • Principal Investigator: Pengzhe Qin, MD
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Contact: Dong Xu, MD, PhD
    • Principal Investigator: Dong Xu, MD, PhD
  • Shanghai, China
    • Recruiting
    • Changhai Hospital
    • Contact: Enda Yu, MBBS
    • Principal Investigator: Enda Yu, MBBS
  • Shanghai, China
    • Recruiting
    • Shanghai Municipal Center for Disease Control and Prevention
    • Contact: Kai Gu
    • Principal Investigator: Kai Gu, PhD
  • Tianjin, China
    • Recruiting
    • Tianjin Nankai Hospital
    • Contact: Ximo Wang, MD, PhD
    • Principal Investigator: Ximo Wang, MD, PhD
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Ping Lan, MD, PhD; Phone Number: +86-13710316769; Email: lanping@mail.sysu.edu.cn
      • Principal Investigator: Ping Lan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stool-based SDC2 DNA methylation test group; Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.	Diagnostic test: Stool-based SDC2 DNA methylation test; Stool-based SDC2 DNA methylation test
ACTIVE_COMPARATOR: Fecal immunochemical test group; Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.	Diagnostic test: Fecal immunochemical test; Fecal immunochemical test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods	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.	One year

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Changhai Hospital; Peking University People's Hospital; Peking University Cancer Hospital & Institute; Second Affiliated Hospital, School of Medicine, Zhejiang University; Tianjin Nankai Hospital; Shanghai Municipal Center for Disease Control and Prevention; Guangzhou Center for Disease Control and Prevention
• Investigators: Principal Investigator: Kai Gu, MD, Shanghai Municipal Center for Disease Control and Prevention; Principal Investigator: Enda Yu, MBBS, Changhai Hospital; Principal Investigator: Ximo Wang, MD, PhD, Tianjin Nankai Hospital; Principal Investigator: Shan Wang, MD, PhD, Peking University People's Hospital; Principal Investigator: Jiahua Leng, MD, PhD, Peking University Cancer Hospital & Institute; Principal Investigator: Dong Xu, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University; Principal Investigator: Pengzhe Qin, MD, Guangzhou Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 15, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Colorectal cancer screening; Fecal immunochemical test; SDC2 DNA Methylation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Adenoma; Colorectal Neoplasms; Polyps; Adenomatous Polyps
• Other Study ID Numbers: CCRCSIP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No