|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of California, Davis |
|---|---|
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00368615 |
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: | Case Control, Prospective |
| Official Title: | Characterization of the Melanoma-Specific Immune Response |
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: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Subjects with biopsy proven melanoma
|
|
2
Age-matched controls (no evidence of 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.
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:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Nava | 916-734-1438 | jennifer.nava@ucdmc.ucdavis.edu |
| Contact: Sepideh Bagheri, M.D. | 916-734-6547 | sepideh.bagheri@ucdmc.ucdavis.edu |
| United States, California | |
| University of California, Davis Department of Dermatology | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Emanual Maverakis, M.D. 916-734-1438 emanual.maverakis@ucdmc.ucdavis.edu | |
| Contact: Jennifer Nava 916-734-1438 jennifer.nava@ucdmc.ucdavis.edu | |
| Principal Investigator: Emanual Maverakis, M.D. | |
| Principal Investigator: | Emanual Maverakis, M.D. | University of California, Davis |
More Information
| Responsible Party: | University of California Davis ( Emanual Mavarakis, MD ) |
| Study ID Numbers: | 200513097-1 |
| Study First Received: | August 24, 2006 |
| Last Updated: | August 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00368615 |
| Health Authority: | United States: Institutional Review Board |
|
melanoma malignant melanoma |
|
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
