NCT06258434

Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening

Liquid Biopsy Based Multiomics Study for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients: an Prospective, Single Bind Observational Study (COLO-LIMULOID)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed liquid biopsy based multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients and patients with confirmed CRC, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multiomics Colorectal Cancer (CRC) screening test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.

Detailed description

The study will be carried out in 5 hospitals throughout China. Patients who are at high risk of developing CRC or confirmed CRC and willing to conduct colonoscopy examination will be asked to collect blood prior to bowl preparation for multiomics CRC screening test which using Reduced Representation Bisulfite Sequencing (RRBS) technology to obtain multidimensional variation information on cell-free DNA (cfDNA) methylation, end sequence, fragment size distribution, and copy number variation in the blood, and integrate analysis through machine learning algorithms to accurately assess the risk of colorectal cancer and advanced adenoma. and will be asked to collect stool sample for commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference. The diagnosis information of each sample was blind to the participants who conduct the multiomics profiling, as well as the informatics who perform the integrate analysis.

Conditions

• Colorectal Cancer
• Adenomatous Polyps
• Adenoma
• Advanced Adenoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)	Patients who are at high risk of developing CRC or confirmed CRC and willing to conduct colonoscopy examination will be asked to collect blood prior to bowl preparation for multiomics CRC screening test which using Reduced Representation Bisulfite Sequencing (RRBS) technology to obtain multidimensional variation information on cell-free DNA (cfDNA) methylation, end sequence, fragment size distribution, and copy number variation in the blood, and integrate analysis through machine learning algorithms to accurately assess the risk of colorectal cancer and advanced adenoma. and will be asked to collect stool sample for commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference. The diagnosis information of each sample was blind to the participants who conduct the multiomics profiling, as well as the informatics who perform the integrate analysis.

Timeline

• Start date: 2024-02-10
• Primary completion: 2024-08-10
• Completion: 2024-09-10
• First posted: 2024-02-14
• Last updated: 2024-02-14

Locations

1 site across 1 country: China