A Multicenter Clinical Trial of Stool-based DNA Testing for Early Detection of Colon Cancer in China

NCT04722055 | Completed

• 1 other identifier: KLM2020-02
• Study Type: observational
• Target: 1,273
• Locations: 1 country
• Sites: 1

Brief Summary

According to data from Global Cancer Statistics 2018, colorectal cancer (CRC) ranks second in incidence and fifth in mortality among all cancers in China. The underlying neoplastic progression from adenoma to CRC endures up to 10 years, providing an extended window for CRC detection and screening. Currently, fecal occult blood test (FOBT) and colonoscopy are the main diagnostic and screening methods for CRC in Chinese clinical practice. However, due to low patients' compliance with colonoscopy and poor sensitivity of FOBT, a large proportion of CRC could not be effectively diagnosed and treated at early stage. Therefore, noninvasive fecal DNA detection approach with enhanced performance is urgently needed in clinic. The aim of this trial is to evaluate effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR) for auxiliary diagnosis of colorectal cancer. By assessing the level of DNA methylation of certain genes in human stool, the test can indicate whether cancerous and precancerous lesions exist in the areas of colon and rectum.

Conditions

Colorectal Cancer; Advanced Adenocarcinoma; Hyperplastic Polyp; Colorectal Neoplasms; Digestive System Neoplasm; Neoplasms

Keywords

Colorectal Cancer; Colon Cancer; Stool DNA test; fecal DNA test; Methylation Biomarkers; Colonoscopy; Cancer Screening

Outcome Measures

Primary Outcomes (4)

• Sensitivity

  Sensitivity is the true positive fraction of participants with colorectal cancer.

  Two years

• Specificity

  Specificity is the true negative fraction of participants without colorectal cancer.

  Two years

• Consistency rate

  Consistency rate is the fraction of both true positive and negative diagnostic test results among all participants.

  Two years

• Kappa coefficient

  Kappa coefficient is the consistency analysis of the extent of agreement between the test results of Colosafe 2.0 and reference colonoscopy.

  Two years

Study Arms (1)

Study group

Single arm of continuously enrolled participants. All eligible participants will be included in the study according to the inclusion criteria. In addition to giving stool samples for multigene methylation test, eligible participants need to undergo colonoscopy examination and have their biopsies taken when necessary (gold standard).

Diagnostic Test: Multigene Methylation Detection Kit

Interventions

Multigene Methylation Detection Kit DIAGNOSTIC_TEST

Eligible participants are required to take stool samples for multigene methylation detection and gene sequencing, undergo colonoscopy examination, and have a biopsy when necessary (gold standard).

Also known as: Colosafe 2.0

Study group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 40-79 years old, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. Up to 1113 participants will be enrolled.

You may qualify if:

• Participants must also meet the following three criteria to be included in this study:
• To be 40 to 79 years old, regardless of gender;
• To participate voluntarily and sign Informed Consent Form;
• To satisfy any of the following three conditions:
• Patients with colorectal cancer confirmed or suspected by colonoscopy or pathological biopsy;
• Patients with gastrointestinal disease or normal population to be examined by colonoscopy;
• Patients who are planning to undergo colonoscopy or have colonoscopy results from other interfering diseases.

You may not qualify if:

• Patients with any of the following conditions shall be excluded:
• To have had radical resection of colorectal cancer before enrollment in this study;
• To have been deemed ineligible to participate in the study by the principal investigator due to various other reasons.

Sponsors & Collaborators

• Creative Biosciences (Guangzhou) Co., Ltd.: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Isolated human DNA from stool samples

MeSH Terms

Conditions

Colorectal Neoplasms; Digestive System Neoplasms; Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Xianrang Song, PhD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: January 26, 2021
• Primary Completion: January 19, 2022
• Study Completion: August 8, 2022
• Last Updated: October 21, 2022

Record last verified: 2011-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)