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

Primary Purpose

Colorectal Cancer, Colorectal Adenomatous Polyp, Screening

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stool-based SDC2 DNA methylation test
Fecal immunochemical test
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal cancer screening, SDC2 DNA Methylation, Fecal immunochemical test

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • Beijing Cancer HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Guangzhou Center for Disease Control and PreventionRecruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • Changhai HospitalRecruiting
  • Shanghai Municipal Center for Disease Control and PreventionRecruiting
  • Tianjin Nankai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stool-based SDC2 DNA methylation test group

Fecal immunochemical test group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
February 15, 2020
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Shanghai Municipal Center for Disease Control and Prevention, Changhai Hospital, Tianjin Nankai Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, School of Medicine, Zhejiang University, Guangzhou Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04221854
Brief Title
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Shanghai Municipal Center for Disease Control and Prevention, Changhai Hospital, Tianjin Nankai Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, School of Medicine, Zhejiang University, Guangzhou Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Adenomatous Polyp, Screening
Keywords
Colorectal cancer screening, SDC2 DNA Methylation, Fecal immunochemical test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will received either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stool-based SDC2 DNA methylation test group
Arm Type
Experimental
Arm Description
Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.
Arm Title
Fecal immunochemical test group
Arm Type
Active Comparator
Arm Description
Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.
Intervention Type
Diagnostic Test
Intervention Name(s)
Stool-based SDC2 DNA methylation test
Intervention Description
Stool-based SDC2 DNA methylation test
Intervention Type
Diagnostic Test
Intervention Name(s)
Fecal immunochemical test
Intervention Description
Fecal immunochemical test
Primary Outcome Measure Information:
Title
The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is average risk for development of colorectal cancer. Subject is able and willing to undergo a screening colonoscopy within six months of enrollment. Subject is 45 to 80 years of age inclusive. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study. Subject is able and willing to provide stool samples according to written instructions provided to them. Exclusion Criteria: Subject has any condition which, in the opinion of the investigator should preclude participation in the study. Subject has a history of colorectal cancer or adenoma. Subject has a history of other digestive tract cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Lan, M.D., Ph.D.
Phone
+86-13710316769
Email
lanping@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yufeng Chen, MD, PhD
Phone
+86-13710555130
Email
chenyf78@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Gu, MD
Organizational Affiliation
Shanghai Municipal Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enda Yu, MBBS
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ximo Wang, MD, PhD
Organizational Affiliation
Tianjin Nankai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shan Wang, MD, PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiahua Leng, MD, PhD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong Xu, MD, PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pengzhe Qin, MD
Organizational Affiliation
Guangzhou Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Lan, MD, PhD
Phone
+86-13710316769
Email
lanping@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Ping Lan, MD, PhD
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiahua Leng, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jiahua Leng, MD, PhD
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan Wang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Shan Wang, MD, PhD
Facility Name
Guangzhou Center for Disease Control and Prevention
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengzhe Qin, MD
First Name & Middle Initial & Last Name & Degree
Pengzhe Qin, MD
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Xu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dong Xu, MD, PhD
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enda Yu, MBBS
First Name & Middle Initial & Last Name & Degree
Enda Yu, MBBS
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, MD
Facility Name
Shanghai Municipal Center for Disease Control and Prevention
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Gu
First Name & Middle Initial & Last Name & Degree
Kai Gu, PhD
Facility Name
Tianjin Nankai Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ximo Wang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ximo Wang, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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