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

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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02087878

Acronym

HSTCL

Enrollment

Registered

2014-03-14

Start date

2014-03-31

Completion date

2019-09-30

Last updated

2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Hepatosplenic T-Cell Lymphoma, Ulcerative Colitis (UC)

Keywords

Hepatosplenic T-Cell Lymphoma

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

1 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results