Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening

NCT ID: NCT06258434

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2024-09-10

Brief 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

Study Design

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

Study Groups

high risk CRC screening group

Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer or CRC patients

multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)

Intervention Type: DIAGNOSTIC_TEST

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.

CRC group

Prospective enrollment of subjects with confirmed colorectal cancer

multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

fecal immunochemical test（FIT ）; diagnostic colonoscopy

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sheng Dai

Principal Investigator, head of medical affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sheng dai, MD&PhD

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

sheng dai, MD&PhD

Role: CONTACT

daimd@zju.edu.cn

13575472669

Other Identifiers

20211204-31

Identifier Type: -

Identifier Source: org_study_id