ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01804166
Recruitment Status : Recruiting
First Posted : March 5, 2013
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

February 1, 2013
March 5, 2013
November 29, 2017
March 21, 2013
June 25, 2020   (Final data collection date for primary outcome measure)
Identify Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL) [ Time Frame: Approximately up to 8 years ]
Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis.
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. ]
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.
Complete list of historical versions of study NCT01804166 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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 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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Hepatosplenic T-Cell Lymphoma
  • 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.
    Other Name: Remicade
  • 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.
    Other Name: Simponi
IBD patients with HSTCL
Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
Interventions:
  • Drug: Infliximab
  • Drug: Golimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
June 25, 2020
June 25, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
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
 
 
NCT01804166
CR100938
CR100938 ( Registry Identifier: Janssen Scientific Affairs, LLC )
No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
Not Provided
Study Director: Study Director Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP