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 : November 10, 2021
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Condition or disease |
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Melanoma |
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Characterization of the Melanoma-Specific Immune Response |
Study Start Date : | August 2007 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | August 2022 |

Group/Cohort |
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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.
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2
Age-matched controls (no evidence of melanoma)
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- 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 - 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Biopsy diagnosis of malignant melanoma
- Have had a biopsy diagnosis of malignant melanoma in the past
Exclusion Criteria:
- Patients taking immunosuppressive medications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368615
Contact: Emanual Maverakis, M.D. | 916-734-1267 | emaverakis@ucdavis.edu | |
Contact: Lauren Downing | 916-551-2635 | ladowning@ucdavis.edu |
United States, California | |
University of California, Davis Department of Dermatology | Recruiting |
Sacramento, California, United States, 95816 | |
Contact: Emanual Maverakis, M.D. 916-734-6556 emaverakis@ucdavis.edu | |
Contact: Lauren Downing 916-551-2635 ladowning@ucdavis.edu | |
Principal Investigator: Emanual Maverakis, M.D. |
Principal Investigator: | Emanual Maverakis, M.D. | University of California, Davis |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00368615 |
Other Study ID Numbers: |
362163 |
First Posted: | August 25, 2006 Key Record Dates |
Last Update Posted: | November 10, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
melanoma malignant melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |