Clinical trial NCT04722055: A Multicenter Clinical Trial of Stool-based DNA Testing for Early Detection of Colon Cancer in China
Official title: A Multicenter Clinical Trial of Human Multigene Methylation Detection Kit (Fluorescent PCR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 1273
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Sensitivity
timeFrame: Two years
measure: Specificity
timeFrame: Two years
measure: Consistency rate
timeFrame: Two years
measure: Kappa coefficient
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Xianrang Song, PhD
role: PRINCIPAL_INVESTIGATOR
References: