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Characterization of the Melanoma-Specific Immune Response (Melanoma)

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ClinicalTrials.gov Identifier: NCT00368615
Recruitment Status : Recruiting
First Posted : August 25, 2006
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date August 24, 2006
First Posted Date August 25, 2006
Last Update Posted Date May 27, 2020
Study Start Date August 2007
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2017)
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.
Original Primary Outcome Measures
 (submitted: August 24, 2006)
melanoma
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2017)
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
Original Secondary Outcome Measures
 (submitted: August 24, 2006)
melanoma
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of the Melanoma-Specific Immune Response
Official Title Characterization of the Melanoma-Specific Immune Response
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population 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).
Condition Melanoma
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 24, 2006)
20
Original Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients taking immunosuppressive medications
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Emanual Maverakis, M.D. 916-734-1267 emaverakis@ucdavis.edu
Contact: Lauren Downing 916-551-2635 ladowning@ucdavis.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00368615
Other Study ID Numbers 362163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor University of California, Davis
Collaborators Not Provided
Investigators
Principal Investigator: Emanual Maverakis, M.D. University of California, Davis
PRS Account University of California, Davis
Verification Date May 2020