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Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China

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ClinicalTrials.gov Identifier: NCT04515082
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Study Description
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Brief Summary:

The primary objective is to determine sensitivity, specificity, positive predictive value and negative predictive value of a bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) for colorectal cancer and advanced precancerous neoplasm(including advanced adenoma and advanced serrated lesions) screening, using colonoscopy as the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.

The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test (FIT) assay, both with respect to cancer and advanced precancerous neoplasm. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.


Condition or disease Intervention/treatment
Colorectal Neoplasm Colorectal Cancer Adenomatous Polyps Adenoma Advanced Adenoma Serrated Polyp Diagnostic Test: Stool-based SDC2 and SFRP2 DNA methylation test Diagnostic Test: FIT

Detailed Description:
This study is a multi-center diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Navy/Second Military Medical University), which is conducted at about 30 digestive endoscopy centers nationwide in China, with the expectation of including approximately 4,800 patients. Subjects willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for stool DNA test and commercially available FIT assay. The basic characteristics of subjects, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. Colonoscopy and histopathologic examination are used as reference.
Study Design
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Study Type : Observational
Estimated Enrollment : 4800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China, a Multi-Center Study
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Stool-based SDC2 and SFRP2 DNA methylation test
    A diagnostic device measuring syndecan 2 (SDC2) and secreted frizzled-related protein 2 (SFRP2) methylation status in stool DNA to detect colorectal cancer
    Other Name: Colowell
  • Diagnostic Test: FIT
    Fecal immunochemical test

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity, specificity, positive predictive value and negative predictive value of bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) with comparison to colonoscopy, both with respect to cancer and advanced precancerous neoplasm. [ Time Frame: Through study completion, an average of 1 year ]
    A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Advanced precancerous neoplasm includes both advanced adenoma and advanced serrated lesions. The DNA test includes the methylation status of SDC2 and SFRP2. The tests were processed independently of colonoscopy procedure.


Secondary Outcome Measures :
  1. To compare the performance of the bi-target stool DNA testing to a commercially available FIT assay, both with respect to cancer and advanced precancerous neoplasm. [ Time Frame: Through study completion, an average of 1 year ]
    A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. The stool DNA and FIT test were performed on the same stool sample.


Biospecimen Retention:   Samples With DNA
Stool sample

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who referred to the outpatient and received colonoscopy.
Criteria

Inclusion Criteria:

  1. Age between 40 to 85 years old, the gender is not limited
  2. Willing to provide written consent
  3. Able to provide stool sample

Exclusion Criteria:

  1. Unwilling to provide stool samples
  2. Subject with contraindications for bowel preparation or colonoscopy
  3. Subject with known colorectal polyps but not removed
  4. Subject with inflammatory bowel disease
  5. History of colonoscopy within 1 year
  6. History of colorectal cancer
  7. History of hereditary colorectal cancer syndrome (including polyposis)
  8. Active lower gastrointestinal bleeding
  9. Pregnancy
  10. Subject taking anticoagulants such as aspirin and warfarin, or who have coagulopathy
  11. Subject clinically highly suspected with gastrointestinal cancer
  12. Other conditions deemed not suited for the study by investigators

Elimination Criteria:

  1. Ask to withdraw from the study
  2. Unable to get a stool sample
  3. Invalid stool samples to test
  4. Poor or inadequate bowel preparation
  5. Failed to complete the colonoscopy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515082


Contacts
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Contact: Zhaoshen Li, MD +86-21-25070552 zhaoshenlismmu@gmail.com
Contact: Yu Bai, MD +86-13564665324 baiyu1998@hotmail.com

Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Zhaoshen Li, MD Changhai Hospital, Navy/Second Military Medical University
More Information
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Publications:

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Responsible Party: Zhaoshen Li, MD, Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04515082    
Other Study ID Numbers: CHEC2020-033
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Adenoma
Adenomatous Polyps
Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type