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NCT01804166 · ClinicalTrials.gov registry record · Phase 4
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)
A Phase 4 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT01804166: Completed Phase 4 study, sponsored by Janssen Scientific Affairs.
NCT01804166 is a Phase 4 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01804166, a Phase 4 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In addition, demographic and clinical patient information will be collected. The study will be conducted in North America. Patients eligible for enrollment include males or females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be identified through the sponsor's adverse event reporting systems. Cases reported to the sponsor's Medical Information Center will be queried to ascertain if the reporter is interested in participating in the study. Where appropriate, cases may also be identified through the sponsor's new or on-going clinical trials and registries. Samples may be collected from living patients or from stored tissue of deceased patients. This study will not restrict or introduce any therapeutic interventions, including medications. All patients will continue to be managed by their personal physicians. No healthy subjects will be enrolled in this study.
Primary Outcome
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.
Interventions
- DRUG Infliximab
- DRUG Golimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-03-21 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 4 |
What the finished NCT01804166 record still lists
NCT01804166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Infliximab is the first listed.
NCT01804166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01804166 about?
NCT01804166 is a clinical study titled "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)". This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample....
What is the current status of trial NCT01804166?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2013-03-21. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT01804166?
The interventions under investigation include: Infliximab (DRUG), Golimumab (DRUG).
Who is sponsoring clinical trial NCT01804166?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01804166's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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