Clinical trial · Observational
Non-invasive Risk Stratification of CR AMN/SSP
Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
NCT02476682CI-TRIAL-00087749FITterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): facility required for analysis of samples is no longer able to facilitate analysis
Summary
Brief summary (as posted)
The purpose of this study is to determine the clinical utility of stool and blood methylation tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood or stool samples will be collected | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Normal subjects
- description
- blood or stool samples will be collected from people referred for screening colonoscopy
- interventionNames
- Other: blood or stool samples will be collected
- label
- Colorectal cancer
- description
- blood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection
- interventionNames
- Other: blood or stool samples will be collected
- label
- Polyps <10mm and no high risk features
- description
- blood or stool samples will be collected from people with no polyps or low risk polyps (\<10mm, no villous component or dysplasia) detected at colonoscopy
- interventionNames
- Other: blood or stool samples will be collected
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals capable and willing of proving satisfactory informed consent * Individuals with colonic lesions larger than 20mm * Individuals diagnosed with laterally spreading or sessile polyp morphology * Individuals schedules for screening colonoscopy and with no prior history of CRC * Ability and willingness to collect stool sample at home * Ability and willingness to undergo venepuncture procedure Exclusion Criteria: * Individuals not able or unwilling to provide informed consent * Individuals less than 18 year of age * Individuals who undergo an incomplete colonoscopy or resection, which raises doubt as to the status of the colon (post-hoc exclusion) * Individuals with a prior history of CRC * Individuals with a history of Irritable Bowel Disease (IBD), hereditary nonpolyposis colorectal cancer (HNPCC) or Familial adenomatous polyposis (FAP) * Individuals with bleeding diathesis * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.