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)
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Lymphoma, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/19/2018 |
| Start Date: | March 21, 2013 |
| End Date: | June 25, 2020 |
| 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: |
| Email: | JNJ.CT@sylogent.com |
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.
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.
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
We found this trial at
3
sites
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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