Study Stopped
slow accrual
Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease
Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics
3 other identifiers
observational
7
0 countries
N/A
Brief Summary
RATIONALE: Studying samples of blood from patients with cancer, hepatitis C, or Crohn disease in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer and other diseases. PURPOSE: This laboratory study is looking at the effect of biological therapy on biomarkers in patients with untreated hepatitis C, metastatic melanoma, or Crohn disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedApril 25, 2016
April 1, 2016
1.8 years
May 9, 2009
April 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Systemic indoleamine 2, 3 dioxygenase levels in tissue at baseline and 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients)
at baseline and 3 to 4 weeks after treatment is initiated
Serum TRP levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients)
at baseline and at 3 to 4 weeks after treatment is initiated
Serum KYN levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients)
at baseline and at 3 to 4 weeks after treatment is initiated
Interventions
Eligibility Criteria
patients with Hepatitis C; Anti-TNF in patients with active inflammatory bowel disease(IBD); anti-CTLA Ig in patients with metastatic melanoma
You may qualify if:
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Acute or chronic hepatitis C
- Receiving pegylated interferon alfa and ribavirin
- Metastatic melanoma
- Receiving ticilimumab
- Crohn disease
- Received prior infliximab
You may not qualify if:
- Not specified
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Biospecimen
* Serum/plasma samples will be collected from patients being treated for untreated acute and chronic Hepatitis C with pegylated IFN-α and ribavirin * Serum/plasma samples will be collected from patients being treated for metastatic melanoma with CYP-206,675 * Serum/plasma samples previously collected
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeffrey A. Sosman, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Medical Oncologist
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
October 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
April 25, 2016
Record last verified: 2016-04