Clinical trial · Observational
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
- 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 multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| FIT | Diagnostic Test | — | UNRESOLVED |
| Multitarget stool FIT-DNA test - ColoClear | 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
- interventionNames
- Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear
- Diagnostic Test: FIT
- Procedure: Colonoscopy
- label
- CRC group
- description
- Retrospective enrollment of subjects with confirmed colorectal cancer
- interventionNames
- Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear
- Diagnostic Test: FIT
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
- timeFrame
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 stool sample 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 stool 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