Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening

Colorectal Cancer Clinical Trial

— COLO-LIMULOID  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258434
• Other study ID #: 20211204-31
• Status: Not yet recruiting
• Start date: February 10, 2024
• Est. completion date: September 10, 2024

Study information

• Verified date: February 2024
• Source: Sir Run Run Shaw Hospital
• Contact: sheng dai, MD&PhD
• Phone: 13575472669
• Email: daimd[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 10, 2024
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

Willing to provide written consent Able to provide blood and stool samples

For high risk CRC screening group:

Scheduled for colonoscopy voluntarily or by physician prescription

CRC high risk profile as defined below:

History of FIT positivity Family history of CRC Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress

For CRC group:

Confirmed CRC patients No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures

Exclusion Criteria:

Unwilling to provide blood samples FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis Prior history of colonoscopy within the past 5 years and removal of lesions History of CRC other conditions deemed not suited for the study by investigators

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Advanced Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) with comparison to colonoscopy	A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The 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. The tests were processed independently of colonoscopy procedure, which was blind to investigators who perform the multiomics profiling and integrate data analysis.	Through study completion, an average of 6 months
Secondary	Sensitivity of the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) with comparison to FIT, with respect to advanced adenoma (AA) and CRC	A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) and FIT test were performed on the blood and stool sample of the same patient.	Through study completion, an average of 6 months