Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Advanced Adenoma | Adenoma | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- high risk CRC screening group
- description
- Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer or CRC patients
- interventionNames
- Diagnostic Test: multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)
- label
- CRC group
- description
- Prospective enrollment of subjects with confirmed colorectal cancer
- interventionNames
- Diagnostic Test: multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)
Primary outcomes (1)
- measure
- Sensitivity and specificity of the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) with comparison to colonoscopy
- timeFrame
- Through study completion, an average of 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available