Clinical trial · Observational
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
NCT02503696CI-TRIAL-00023440completedClinicalTrials.gov clinicaltrialsProvenance
- 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 of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Diseases | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Digestive System Diseases | — | UNRESOLVED | — |
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stool Collection Kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- IBD
- description
- Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings.
- interventionNames
- Device: Stool Collection Kit
Primary outcomes (1)
- measure
- Sensitivity and Specificity of the Exact CRC diagnostic screening test.
- timeFrame
- 15 months
- description
- The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD. * Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia. * Written informed consent document signed and dated by the subject. Exclusion Criteria: * Any condition that in the opinion of the investigator should preclude participation in the study. * A history of aerodigestive tract cancer. * Prior colorectal resection, except ileocolic resection in Crohn's disease patients. * IBD limited only to the rectum. * Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.
References
Publications (0)
Data not yet available
No reference posted for this study.