MedTrace Logo

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)

NCT01804166 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-02-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Hepatosplenic T-Cell Lymphoma

Interventions

DRUG

Infliximab

This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians.

DRUG

Golimumab

This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Study Director · Janssen Scientific Affairs, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-21
Primary Completion
2020-02-28
Completion
2020-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804166 on ClinicalTrials.gov