Characterization of the Melanoma-Specific Immune Response
Recruitment status was Recruiting
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Characterization of the Melanoma-Specific Immune Response |
- melanoma [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- melanoma [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Subjects with biopsy proven melanoma
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2
Age-matched controls (no evidence of melanoma)
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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).
Inclusion Criteria:
- Biopsy diagnosis of malignant melanoma
- Have had a biopsy diagnosis of malignant melanoma in the past
Exclusion Criteria:
- Patients taking immunosuppressive medications
Contacts and Locations| Contact: Emanual Maverakis, MD | 916-734-1267 | emaverakis@ucdavis.edu |
| Contact: Jamie Chapman | 916-734-1267 | jamie.chapman@ucdmc.ucdavis.edu |
| United States, California | |
| University of California, Davis Department of Dermatology | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Emanual Maverakis, MD 916-734-6556 emaverakis@ucdavis.edu | |
| Contact: Jamie Chapman 916-734-1267 jamie.chapman@ucdmc.ucdavis.edu | |
| Principal Investigator: Emanual Maverakis, MD | |
| Principal Investigator: | Emanual Maverakis, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Emanual Mavarakis, MD, University of California Davis |
| ClinicalTrials.gov Identifier: | NCT00368615 History of Changes |
| Other Study ID Numbers: | 200513097-1 |
| Study First Received: | August 24, 2006 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
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melanoma malignant melanoma |
Additional relevant MeSH terms:
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on June 17, 2013