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)
Condition: Hepatosplenic T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: Infliximab; Golimumab
Intervention description: This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians.; This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians.
Intervention MeSH terms: Infliximab; Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Healthy volunteers: No
Keywords: Lymphoma, T-Cell, Peripheral, Infliximab, Golimumab, Remicade, Simponi, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease

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.
    

Eligibility criteria:

        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