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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02087878
Other study ID # F14-258
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 31, 2014
Est. completion date September 30, 2019

Study information

Verified date November 2019
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Year to 99 Years
Eligibility 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


Locations

Country Name City State
Italy AOU Pisana /ID# 208952 Pisa

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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