We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterization of the Melanoma-Specific Immune Response (Melanoma)

This study is currently recruiting participants.
Verified May 2017 by University of California, Davis
Sponsor:
ClinicalTrials.gov Identifier:
NCT00368615
First Posted: August 25, 2006
Last Update Posted: May 30, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
August 24, 2006
August 25, 2006
May 30, 2017
August 2007
November 2017   (Final data collection date for primary outcome measure)
melanoma - peripheral blood [ Time Frame: 2 Years ]
Peripheral blood will be collected from adults ages 18-85 years old. These samples will then be used for PCR analysis and to generate melanoma-specific T cell clones. If the participant requires a palliative resection of a melanoma tumor(s) then tissue from the tumor will be used to characterize the melanoma's interaction with the immune system and to generate melanoma-specific cell lines. T cell clones isolated from participant's peripheral blood will then be assayed for in-vitro responsiveness to these cell lines. All experiments will be conducted in-vitro.
melanoma
Complete list of historical versions of study NCT00368615 on ClinicalTrials.gov Archive Site
melanoma - biopsy [ Time Frame: 2 Years ]
Patients will not be required to have a biopsy to participate in the study but those who give their consent will undergo a skin biopsy. The biopsy will be used to characterize the skin-infiltrating inflammatory cells. The gene-expression profile of these cells will be determined. Each patient who provides consent will undergo two biopsies, one of lesional skin and the other of normal lesional skin as control. Patients who develop multiple cutaneous tumors may be reconsented for an additional two biopsies
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 ages 18-85 years old with biopsy proven melanoma. Peripheral blood will be collected from adults ages 18-85 years old. These samples will then be used for PCR analysis and to generate melanoma-specific T cell clones. If the participant requires a palliative resection of a melanoma tumor(s) then tissue from the tumor will be used to characterize the melanoma's interaction with the immune system and to generate melanoma-specific cell lines. T cell clones isolated from participant's peripheral blood will then be assayed for in-vitro responsiveness to these cell lines. All experiments will be conducted in-vitro.
  • 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 2017
November 2017   (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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
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
Not Provided
Plan to Share IPD: 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
May 2017