Characterization of the Melanoma-Specific Immune Response (Melanoma)
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| ClinicalTrials.gov Identifier: NCT00368615 |
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Recruitment Status :
Recruiting
First Posted : August 25, 2006
Last Update Posted : November 10, 2021
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Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
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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.
| Condition or disease |
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| Melanoma |
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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
| 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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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
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.
Information from the National Library of Medicine
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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 |
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).
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
Information from the National Library of Medicine
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
Contacts
| Contact: Emanual Maverakis, M.D. | 916-734-1267 | emaverakis@ucdavis.edu | |
| Contact: Lauren Downing | 916-551-2635 | ladowning@ucdavis.edu |
Locations
| 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. | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Emanual Maverakis, M.D. | University of California, Davis |
Additional Information:
| 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 |
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 |