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

Colorectal Cancer Clinical Trial

Official title:

A Multicenter Clinical Trial of Human Multigene Methylation Detection Kit (Fluorescent PCR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722055
• Other study ID #: KLM2020-02
• Status: Completed
• Start date: January 26, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: November 2011
• Source: Creative Biosciences (Guangzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1273
• Est. completion date: August 8, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Adenocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Hyperplastic Polyp
• Neoplasms

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Creative Biosciences (Guangzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity is the true positive fraction of participants with colorectal cancer.	Two years
Primary	Specificity	Specificity is the true negative fraction of participants without colorectal cancer.	Two years
Primary	Consistency rate	Consistency rate is the fraction of both true positive and negative diagnostic test results among all participants.	Two years
Primary	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