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 a single blood sample, if possible, and obtain tissue samples from the biopsy specimen that was used to diagnose HSTCL. 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 the US only. The study population will include IBD patients in the US with HSTCL who are identified through the sponsor's adverse event reporting systems. Cases of HSTCL will be identified through postmarketing adverse event reporting (eg, spontaneous reports, reports from late phase clinical trials, reports from patient registries) or from the sponsor's new or ongoing clinical trials. Eligible for enrollment are male or female patients of any age who have a confirmed diagnosis of HSTCL. There is no study-related therapeutic intervention and this protocol 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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)|
- Collection of samples to identify biomarkers [ Time Frame: Single timepoint of collection. Qualified subjects will be asked to provide samples at one time point (Day 1) during one visit with their study doctor. ] [ Designated as safety issue: No ]The objective of this study is to collect samples from IBD patients diagnosed with HSTCL for the purpose of identifying biomarkers that may allow either earlier evaluation of a patient's risk of developing HSTCL or possibly earlier diagnosis.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
IBD patients with HSTCL
Subjects with Inflammatory Bowel Disease with a dignaosis of Hepatosplenic T-cell lymphoma
Other: Collection of samples
There is no study-related therapeutic intervention and this protocol will not restrict or introduce any therapeutic interventions, including medications.
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
|United States, Virginia|
|Norfolk, Virginia, United States|
|Study Director:||Sujana Yerram, MD||Janssen Services|