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 currently recruiting participants.
Verified April 2014 by Janssen Scientific Affairs, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01804166
First received: February 1, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose HSTCL and, if possible, to obtain a single blood sample, a buccal swab sample and 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. The study population will include IBD patients in North America 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.


Condition Intervention Phase
Hepatosplenic T-Cell Lymphoma
Biological: Collection of samples
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IBD patients with HSTCL
Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
Biological: Collection of samples
There is no study-related therapeutic intervention and this protocol will not restrict or introduce any therapeutic interventions, including medications.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Inflammatory Bowel Disease with a confirmed diagnosis of Hepatosplenic T-cell Lymphoma
  • Be willing to provide a tumor biopsy sample for the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804166

Contacts
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

Locations
United States, Virginia
Recruiting
Norfolk, Virginia, United States
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Study Director Janssen Scientific Affairs, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01804166     History of Changes
Other Study ID Numbers: CR100938, CR100938
Study First Received: February 1, 2013
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Janssen Scientific Affairs, LLC:
Lymphoma, T-Cell, Peripheral, Infliximab, Golimumab, Remicade, Simponi, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014