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)

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.

Study Overview

• Status: Withdrawn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

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 Type: Observational

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56124
    • AOU Pisana /ID# 208952

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients of any age with CD or UC in the US with HSTCL who are identified through the Sponsor's adverse event reporting systems and who were exposed to HUMIRA prior to the diagnosis of HSTCL.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of Samples	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.	Up to 6 years

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2014
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Hepatosplenic T-Cell Lymphoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Lymphoma; Ulcer; Crohn Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: F14-258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No