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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02087878
Recruitment Status : Withdrawn (Strategic considerations)
First Posted : March 14, 2014
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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).

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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 : March 31, 2014
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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.



Primary Outcome Measures :
  1. Collection of Samples [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
1-10 mL blood (serum) for biomarker samples; separate consent for 1- 4 mL whole blood sample for DNA isolation. Biopsy tissue and Fine Needle Aspirate also collected. Samples will be shipped to a designated storage facility.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087878


Locations
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Italy
AOU Pisana /ID# 208952
Pisa, Italy, 56124
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02087878    
Other Study ID Numbers: F14-258
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Hepatosplenic T-Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Lymphoma, Non-Hodgkin