A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma (HSTCL)
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|ClinicalTrials.gov Identifier: NCT02087878|
Recruitment Status : Withdrawn (Strategic considerations)
First Posted : March 14, 2014
Last Update Posted : November 22, 2019
|Condition or disease|
|Crohn's Disease Ulcerative Colitis (UC) Hepatosplenic T-Cell Lymphoma|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Multicenter Study to Collect Samples for Future Evaluation of Biomarkers and Genetic Mutations in Patients Exposed to Adalimumab With Crohn's Disease (CD) or Ulcerative Colitis (UC) Who Developed Hepatosplenic T-Cell Lymphoma (HSTCL)|
|Actual Study Start Date :||March 31, 2014|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||September 30, 2019|
To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with HSTCL for the purpose of identifying potential biomarkers and genetic mutations in patients who develop HSTCL.
- Collection of Samples [ Time Frame: Up to 6 years ]A study to bank blood and tissue samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (IBD) patients to developing Hepatosplenic T-Cell Lymphoma (HSTCL). Samples will be obtained from patients who have Crohn's Disease or Ulcerative Colitis, who have been treated with adalimumab and diagnosed with HSTCL.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087878
|AOU Pisana /ID# 208952|
|Pisa, Italy, 56124|
|Study Director:||AbbVie Inc.||AbbVie|