A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population

NCT04786704 | Completed DMC

• 1 other identifier: SDC2_Community
• Study Type: observational
• Target: 12,106
• Locations: 1 country
• Sites: 1

Brief Summary

to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population.

Conditions

Colorectal Cancer; Colorectal Neoplasm; Advanced Adenoma; Adenoma; Serrated Lesion

Keywords

Methylated Syndecan-2(SDC2); Stool DNA; Fecal immunochemical test; Advanced colorectal neoplasia; Asia-Pacific Colorectal Screening score

Outcome Measures

Primary Outcomes (1)

• Detection of advanced colorectal neoplasia

  Advanced colorectal neoplasia is defined as a colorectal adenoma or sessile serrated lesion ≥10 mm, adenoma or sessile serrated lesion with tubulovillous or villous histology, adenoma with high-grade dysplasia, traditional serrated adenoma, or presence of colorectal cancer.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Compliance rate of colonoscopy

  Through study completion, an average of 1 year

• Detection of colorectal cancer

  Through study completion, an average of 1 year

• Detection of colorectal neoplasia

  Through study completion, an average of 1 year

• Efficacy of sDNA in the detection of advanced colorectal neoplasia in high-risk asymptomatic subgroup.

  Through study completion, an average of 1 year

• Efficacy of sDNA in the detection of advanced colorectal neoplasia in low-risk asymptomatic subgroup.

  Through study completion, an average of 1 year

Interventions

Stool-based SDC2 DNA methylation test DIAGNOSTIC_TEST

A diagnostic device measuring syndecan 2(SDC2) methylation status in stool DNA to detect colorectal cancer

Also known as: COLOSAFE

quantitative Fecal immunochemical test DIAGNOSTIC_TEST

A diagnostic device using immunoturbidimetric methods to measure fecal hemoglobin concentration

Also known as: OC-Sensor

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community residents were invited to participate in the evaluation. All the individuals involved would undergo APCS evaluation, qFIT, and sDNA tests. A participator would be considered with increased CRC risk if any of the three is evaluated high-risk or tested positive and would be subsequently recommended to receive timely colonoscopy. When the APCS evaluation shows low or Intermediate risk with both negative results of qFIT and sDNA, participators would be encouraged to undergo colonoscopy based on patient preferences, which could also provide a refference for the prevanlence of advanced colorectal neoplasia in low-risk patients.

You may qualify if:

• Asymptomatic screening individual (no alarm features predicting colorectal cancer including hematochezia, melena, anemia of unknown cause, weight loss, abdominal mass, a positive result of digital rectal examination)
• Age between 45 to 75 years old, the gender is not limited
• Willing to participate and sign informed consent

You may not qualify if:

• Patients with contraindications for bowel preparation or colonoscopy
• Patients with known colorectal adenoma or serrated lesions
• History of colonoscopy within 5 years or polypectomy
• Patients with inflammatory bowel disease
• History of CRC and patients clinically highly suspected with colorectal cancer
• History of hereditary CRC syndrome (including polyposis)
• Patients taking anticoagulants such as aspirin and warfarin within 7 days, or who have coagulopathy
• Pregnancy, or severe organ insufficiency (heart, lung, or kidney et al)

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Gongli Hospital of Shanghai Pudong New Area: collaborator
• Shanghai Songjiang District Central Hospital: collaborator
• Shanghai Jing'an District Central Hospital: collaborator
• Tongji University: collaborator
• Qingyuan People's Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• 900 Hospital of Joint Logistics Support Force of PLA: collaborator
• First Affiliated Hospital of Suzhou Medical College: collaborator
• Affiliated Hospital of Jiangnan University: collaborator
• Traditional Chinese Medicine Hosipital of Kunshan: collaborator
• Ankang Central Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Ningjin County Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (5)

• Niu F, Wen J, Fu X, Li C, Zhao R, Wu S, Yu H, Liu X, Zhao X, Liu S, Wang X, Wang J, Zou H. Stool DNA Test of Methylated Syndecan-2 for the Early Detection of Colorectal Neoplasia. Cancer Epidemiol Biomarkers Prev. 2017 Sep;26(9):1411-1419. doi: 10.1158/1055-9965.EPI-17-0153. Epub 2017 Jun 15.

  PMID: 28619831 BACKGROUND

• Wang J, Liu S, Wang H, Zheng L, Zhou C, Li G, Huang R, Wang H, Li C, Fan X, Fu X, Wang X, Guo H, Guan J, Sun Y, Song X, Li Z, Mu D, Sun J, Liu X, Qi Y, Niu F, Chen C, Wu X, Wang X, Song X, Zou H. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics. 2020 Oct 30;12(1):162. doi: 10.1186/s13148-020-00954-x.

  PMID: 33126908 BACKGROUND

• Gachabayov M, Lebovics E, Rojas A, Felsenreich DM, Latifi R, Bergamaschi R. Performance evaluation of stool DNA methylation tests in colorectal cancer screening: a systematic review and meta-analysis. Colorectal Dis. 2021 May;23(5):1030-1042. doi: 10.1111/codi.15521. Epub 2021 Jan 25.

  PMID: 33410272 BACKGROUND

• Yeoh KG, Ho KY, Chiu HM, Zhu F, Ching JY, Wu DC, Matsuda T, Byeon JS, Lee SK, Goh KL, Sollano J, Rerknimitr R, Leong R, Tsoi K, Lin JT, Sung JJ; Asia-Pacific Working Group on Colorectal Cancer. The Asia-Pacific Colorectal Screening score: a validated tool that stratifies risk for colorectal advanced neoplasia in asymptomatic Asian subjects. Gut. 2011 Sep;60(9):1236-41. doi: 10.1136/gut.2010.221168. Epub 2011 Mar 14.

  PMID: 21402615 BACKGROUND

• Chiu HM, Ching JY, Wu KC, Rerknimitr R, Li J, Wu DC, Goh KL, Matsuda T, Kim HS, Leong R, Yeoh KG, Chong VH, Sollano JD, Ahmed F, Menon J, Sung JJ; Asia-Pacific Working Group on Colorectal Cancer. A Risk-Scoring System Combined With a Fecal Immunochemical Test Is Effective in Screening High-Risk Subjects for Early Colonoscopy to Detect Advanced Colorectal Neoplasms. Gastroenterology. 2016 Mar;150(3):617-625.e3. doi: 10.1053/j.gastro.2015.11.042. Epub 2015 Nov 25.

  PMID: 26627608 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Zhaoshen Li, MD

  Changhai Hospital, Navy/Second Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 8, 2021
• Study Start: March 22, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 25, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

CN (1)