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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04221854
• Other study ID #: CCRCSIP
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2020
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Ping Lan, M.D., Ph.D.
• Phone: +86-13710316769
• Email: lanping[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colorectal Adenomatous Polyp
• Colorectal Cancer
• Colorectal Neoplasms
• Polyps
• Screening

Intervention

Diagnostic Test:
• Stool-based SDC2 DNA methylation test
Stool-based SDC2 DNA methylation test
• Fecal immunochemical test
Fecal immunochemical test

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Guangzhou Center for Disease Control and Prevention	Guangzhou
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Changhai Hospital	Shanghai
China	Shanghai Municipal Center for Disease Control and Prevention	Shanghai
China	Tianjin Nankai Hospital	Tianjin

Sponsors (8)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Beijing Cancer Hospital, Changhai Hospital, Guangzhou Center for Disease Control and Prevention, Peking University People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Municipal Center for Disease Control and Prevention, Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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