Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening
COLO-LIMULOID
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2024
CompletedStudy Start
First participant enrolled
February 10, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2024
CompletedFebruary 14, 2024
February 1, 2024
6 months
February 6, 2024
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Sensitivity of the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) with comparison to FIT, with respect to advanced adenoma (AA) and CRC
Through study completion, an average of 6 months
Study Arms (2)
high risk CRC screening group
Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer or CRC patients
CRC group
Prospective enrollment of subjects with confirmed colorectal cancer
Interventions
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.
Eligibility Criteria
Subjects with high risk of developing CRC and CRC patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Biospecimen
blood and stool sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sheng dai, MD&PhD
Sir Run Run Shaw Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, head of medical affairs
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 14, 2024
Study Start
February 10, 2024
Primary Completion
August 10, 2024
Study Completion
September 10, 2024
Last Updated
February 14, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share