Clinical trial · Observational
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study
- 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)
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Inflammatory Bowel Disease (IBD) | — | UNRESOLVED | — |
| Primary Sclerosing Cholangitis (PSC) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- IBD or PSC
- description
- Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer.
Primary outcomes (1)
- measure
- Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC.
- timeFrame
- 9 months
- description
- With comparison to the colonoscopy results and histopathologic diagnosis of all lesions discovered during colonoscopy and either biopsied or removed during or subsequently removed after colonoscopy.
Secondary outcomes (1)
- measure
- Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD.
- timeFrame
- 9 months
- description
- Subjects with colonoscopic findings of CRC and/or high grade dysplasia (HGD) will be considered to have a positive outcome for composite CRC-HGD sensitivity calculations. Subjects with negative colonoscopic findings will be considered to have a negative outcome.
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. * Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study. * Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC. * Written informed consent document signed and dated by the subject or legally acceptable representative. 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 and without a concurrent PSC diagnosis. * Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject.
References
Publications (0)
Data not yet available