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
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Irritable Bowel Syndrome (IBS), Lymphoma, Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology, Oncology |
Healthy: | No |
Age Range: | 1 - 99 |
Updated: | 12/16/2018 |
Start Date: | March 31, 2014 |
End Date: | March 13, 2022 |
Contact: | Andrea Byars |
Email: | andrea.byars@abbvie.com |
Phone: | +1 847-937-7904 |
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.
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.
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).
biomarkers that predispose inflammatory bowel disease (IBD) patients to developing
Hepatosplenic T-cell Lymphoma (HSTCL).
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.
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