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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hepatosplenic T-Cell Lymphoma

Intervention / Treatment
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* Drug: Infliximab
* Drug: Golimumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBD patients with HSTCL<br>Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma | Drug: Infliximab<br>* This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians.<br>* Other names: Remicade;Drug: Golimumab<br>* This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians.<br>* Other names: Simponi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL) | 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. | Approximately up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, T-Cell, Peripheral, Infliximab, Golimumab, Remicade, Simponi, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease