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

NCT ID: NCT04722055

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2022-08-08

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.

Detailed Description

The multicenter clinical trial will be conducted using a single-blind method. Stool samples provided by participants will be evaluated by Human Multigene Methylation Detection Kit (Fluorescent PCR). The kit will be used to qualitatively detect methylation levels of multiple genes in human stool samples in vitro by using Quantitative Methylation Specific PCR (qMSP). The principle of the method is as follows. First, the target DNA in human stool is extracted by magnetic bead-capture technology and then treated with sodium bisulfite. The sequence of unmethylated DNA will be changed while that of the methylated DNA remains the same after sodium bisulfite treatment. Subsequently, qMSP is employed to detect methylation levels of target genes in addition to ACTB gene (a reference gene). Controls of ACTB gene with and without methylation are tested simultaneously. Result of qMSP is dichotomized as positive and negative based on Ct value obtained. The test result is then verified by Sanger sequencing and compared with that from colonoscopy examination and pathology report. The main evaluation indexes for test performance are sensitivity, specificity, consistency rate, kappa coefficient.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Multigene Methylation Detection Kit

Intervention Type: 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).

Interventions

Multigene Methylation Detection Kit

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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Colosafe 2.0

Eligibility Criteria

Inclusion Criteria

• Participants must also meet the following three criteria to be included in this study:

1. To be 40 to 79 years old, regardless of gender;

2. To participate voluntarily and sign Informed Consent Form;

3. To satisfy any of the following three conditions:

1. Patients with colorectal cancer confirmed or suspected by colonoscopy or pathological biopsy;

2. Patients with gastrointestinal disease or normal population to be examined by colonoscopy;

3. Patients who are planning to undergo colonoscopy or have colonoscopy results from other interfering diseases.

Exclusion Criteria

• Patients with any of the following conditions shall be excluded:

1. To have had radical resection of colorectal cancer before enrollment in this study;

2. To have been deemed ineligible to participate in the study by the principal investigator due to various other reasons.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Creative Biosciences (Guangzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianrang Song, PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Countries

China

Other Identifiers

KLM2020-02

Identifier Type: -

Identifier Source: org_study_id