Trial Outcomes & Findings for A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) (NCT NCT01804166)
NCT ID: NCT01804166
Last Updated: 2025-02-04
Results Overview
Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis.
COMPLETED
PHASE4
1 participants
Approximately up to 8 years
2025-02-04
Participant Flow
Of the 12 subjects the Sponsor attempted to enroll in the study, 1 subject consented and provided a biopsy sample for analysis. No subjects discontinued from the study after enrollment.
Participant milestones
| Measure |
IBD Patients With HSTCL
Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Approximately up to 8 yearsPopulation: Since only one participant completed the study, due to confidentiality issues, no data will be reported.
Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis.
Outcome measures
Outcome data not reported
Adverse Events
IBD Patients With HSTCL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Executive Medical Director
Janssen Scientific Affairs, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER