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

Withdrawn

• Conditions: Crohn's Disease; Hepatosplenic T-Cell Lymphoma; Ulcerative Colitis (UC)

• Registration Number: NCT02087878
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Study Start: 2014-03-31
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of Samples	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.

Trial Locations

Locations (1)

AOU Pisana /ID# 208952; 🇮🇹 Pisa, Italy