Clinical trial NCT04221854: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Colorectal Adenomatous Polyp
Screening
Keywords: Colorectal cancer screening
SDC2 DNA Methylation
Fecal immunochemical test
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Center for Disease Control and Prevention
name: Changhai Hospital
name: Tianjin Nankai Hospital
name: Peking University People's Hospital
name: Peking University Cancer Hospital & Institute
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Guangzhou Center for Disease Control and Prevention
First posted: 2020-01-09
Enrollment: 50000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will received either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Guangzhou
country: China
facility: Guangzhou Center for Disease Control and Prevention
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Municipal Center for Disease Control and Prevention
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
Study officials:
affiliation: Shanghai Municipal Center for Disease Control and Prevention
name: Kai Gu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Enda Yu, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Nankai Hospital
name: Ximo Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Shan Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jiahua Leng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Dong Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Center for Disease Control and Prevention
name: Pengzhe Qin, MD
role: PRINCIPAL_INVESTIGATOR
References: