Characterization of the Melanoma-Specific Immune Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368615
First received: August 24, 2006
Last updated: April 20, 2015
Last verified: April 2015

August 24, 2006
April 20, 2015
August 2007
November 2016   (final data collection date for primary outcome measure)
melanoma [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
melanoma
Complete list of historical versions of study NCT00368615 on ClinicalTrials.gov Archive Site
melanoma [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
melanoma
Not Provided
Not Provided
 
Characterization of the Melanoma-Specific Immune Response
Characterization of the Melanoma-Specific Immune Response

The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.

The aim of the study is to in-vitro characterize and expand T cells specific for melanoma-derived antigens. Peripheral blood with be collected from 20 volunteers with biopsy proven melanoma and 10 age matched controls. Blood will be collected prior to the initiation of chemotherapy. There will be no more than two blood draws per patient. Most patients will receive a single blood draw; however, some participants may be asked to return for a single additional blood draw if investigators were unable to isolate melanoma-specific immune cells after the first blood draw. Two separate blood draws will be the maximum. The interval between these blood draws will be a minimum of 3 months apart. Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the patient's haplotype has been established melanoma-specific T cell clones will be generated from the peripheral blood samples and expanded in-vitro. These clones will then be assayed for specificity against commercially available melanoma cell lines. The T cell clones will also be assayed for reactivity to melanocyte differentiation antigens such as MART-1 and gp100. If the volunteer requires a palliative resection of a melanoma tumor then the patient's own tumor cells may also be used to test the specificity of the isolated T cell clones. All experiments will be conducted in-vitro.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Peripheral blood will be collected prior to initiation of chemotherapy. There will be no more than two blood draws per subject. Most subjects will receive a single blood draw; however, some may be asked to return for an additional blood draw if investigators were unable to isolate melanoma-specific immune cells after the first blood draw. Two separate blood draws will be the maximum.

Non-Probability Sample

Subjects aged 18 years to 85 years who have a biopsy diagnosis of melanoma, and age-matched controls (subjects who do not have a diagnosis of melanoma).

Melanoma
Not Provided
  • 1
    Subjects with biopsy proven melanoma
  • 2
    Age-matched controls (no evidence of melanoma)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2016
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Biopsy diagnosis of malignant melanoma
  • Have had a biopsy diagnosis of malignant melanoma in the past

Exclusion Criteria:

  • Patients taking immunosuppressive medications
Both
18 Years to 85 Years
Yes
Contact: Emanual Maverakis, M.D. 916-734-1267 emaverakis@ucdavis.edu
Contact: Victoria Wells 916-734-1267 victoria.wells@ucdmc.ucdavis.edu
United States
 
NCT00368615
200513097
No
University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Emanual Maverakis, M.D. University of California, Davis
University of California, Davis
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP