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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01804166 |
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Date of registration:
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01/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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) |
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Date of first enrolment:
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March 21, 2013 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01804166 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Scientific Affairs, LLC |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatosplenic T-Cell Lymphoma
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Intervention(s)
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Drug: Golimumab
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Drug: Infliximab
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Primary Outcome(s)
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Identify Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL)
[Time Frame: Approximately up to 8 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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