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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)


Phase 4
N/A
N/A
Open (Enrolling)
Both
Hepatosplenic T-Cell Lymphoma

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Trial Information

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)


Inclusion Criteria:



- Patients with Inflammatory Bowel Disease with a confirmed diagnosis of Hepatosplenic
T-cell Lymphoma

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Collection of samples to identify biomarkers

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Sujana Yerram, MD

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Services

Authority:

United States: Food and Drug Administration

Study ID:

CR100938

NCT ID:

NCT01804166

Start Date:

January 2013

Completion Date:

October 2018

Related Keywords:

  • Hepatosplenic T-cell Lymphoma
  • Lymphoma, T-Cell, Peripheral
  • Colitis
  • Colitis, Ulcerative
  • Crohn Disease
  • Lymphoma
  • Lymphoma, T-Cell

Name

Location

McLean, Virginia  22101