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)

Phase 4

Completed

• Conditions: Hepatosplenic T-Cell Lymphoma
• Interventions: Drug: Infliximab; Drug: Golimumab

• Registration Number: NCT01804166
• Lead Sponsor: Janssen Scientific Affairs, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-05
• Study Start: 2013-03-21
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Results First Submitted: 2021-02-12
• Results First Submitted QC: 2021-02-12
• Results First Posted: 2021-03-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients with Inflammatory Bowel Disease with a confirmed diagnosis of Hepatosplenic T-cell Lymphoma
• Provide written informed consent (either by the patient or his/her legal representative). Consent from a legally acceptable representative of a deceased patient will be obtained for enrollment into the study and sample collection
• Be willing to provide a tumor biopsy sample for the study

Exclusion Criteria

• Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
• Is unable to provide critical clinical and/or demographic patient and/or sample information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBD patients with HSTCL	Infliximab	Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
IBD patients with HSTCL	Golimumab	Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma

Primary Outcome Measures

Name	Time	Method
Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL)	Approximately up to 8 years	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.