HSTCL: 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

Sponsor

AbbVie (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02087878

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Ulcerative Colitis (UC) Hepatosplenic T-Cell Lymphoma

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Other

Time Perspective:

Other

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 :

Mar 31, 2014

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group 1 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.