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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 2 May 2016
Main ID:  NCT00897312
Date of registration: 09/05/2009
Prospective Registration: No
Primary sponsor: Vanderbilt-Ingram Cancer Center
Public title: Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease
Scientific title: Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics
Date of first enrolment: October 2006
Target sample size: 7
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00897312
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Contacts
Name:     Jeffrey A. Sosman, MD
Address: 
Telephone:
Email:
Affiliation:  Vanderbilt-Ingram Cancer Center
Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Not specified

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Melanoma
Intervention(s)
Biological: infliximab
Biological: pegylated interferon alfa
Biological: ticilimumab
Drug: ribavirin
Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Primary Outcome(s)
Serum KYN levels at baseline and at 3 to 4 weeks after treatment is initiated (timepoints for cancer and hepatitis patients) [Time Frame: at baseline and at 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) [Time Frame: at baseline and at 3 to 4 weeks after treatment is initiated]
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) [Time Frame: at baseline and 3 to 4 weeks after treatment is initiated]
Secondary Outcome(s)
Secondary ID(s)
VICC MEL0651
VU-VICC-060614
VU-VICC-MEL-0651
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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