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



Status:Recruiting
Conditions:Colitis, Colitis, Irritable Bowel Syndrome (IBS), Lymphoma, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:1 - 99
Updated:12/16/2018
Start Date:March 31, 2014
End Date:March 13, 2022
Contact:Andrea Byars
Email:andrea.byars@abbvie.com
Phone:+1 847-937-7904

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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)

To collect and store blood and biopsy samples obtained from CD or UC patients exposed to
adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of
identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.

A study to bank 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).

Inclusion Criteria:

- Male or female who has received a single dose of HUMIRA prior to a confirmed diagnosis
of HSTCL.

- Confirmed diagnosis of CD or UC as documented by a Gastroenterologist or physician who
diagnosed the CD or UC.

- Confirmed diagnosis of HSTCL as determined by a biopsy performed on a specimen taken
from the patient.

- Patients 18 years old and older must voluntarily sign and date an IRB/EC approved
Informed Consent Form. For patients younger than 18 years old, a parent or legal
guardian is required to voluntarily sign and date an IRB/EC approved Informed Consent
Form. Pediatric patients will be included in all discussions if possible, in order to
obtain their assent.

Exclusion Criteria:

- Male or female who has not received at least a single dose of adalimumab prior to a
confirmed diagnosis of HSTCL.

- Unconfirmed diagnosis of HSTCL, CD or UC, respectively.

- The patient or the patient's HCP is unwilling to participate in this study.

- The parents or legal guardians (in the case of patients younger than 18 years of age),
who are unable and/or unwilling to consent to the patient's participation in this
study.
We found this trial at
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North Chicago, Illinois 60064
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