Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma
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|ClinicalTrials.gov Identifier: NCT00996827|
Recruitment Status : Terminated (Sufficient samples collected when 73% of target enrollment was reached.)
First Posted : October 16, 2009
Last Update Posted : June 18, 2015
|Condition or disease|
It is well established that ultraviolet radiation (UV) exposure is related to the development of melanoma. There is also evidence that immune reactions are altered after UV exposure in the skin (locally) and perhaps throughout the body (systemically). Additionally, while the role of vitamin D and melanoma development has not been fully established, UV-B exposure is essential for vitamin D production in the skin. Increased sun exposure is also related to the presence of solar elastosis, which might protect (1) or improve survival from melanoma. Thus, melanoma represents a unique model for studying UV exposure, the immune system, and vitamin D. Malignant melanoma is an antigenic cancer; therefore, the role of UV exposure-induced immunosuppression and vitamin D production in the recognition, destruction and growth inhibition of cancerous melanocytes is worth further study.
To underscore the importance of this project, the Scientific Advisory Committee of the Melanoma Research Foundation and the Steering Committee of the Society of Melanoma Research have indicated a need to collect more human data on the host immune response mechanisms in melanoma and also to focus on the skin as a whole microenvironment, moving away from only in vitro experiments.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||December 2013|
- • Evaluate serum 25(OH)-vitamin D concentrations. • Detect the presence of solar elastosis and local immunosuppression in skin biopsy samples • Assess the role of the systemic humoral immune response [ Time Frame: 1 year ]
- • Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
- Serum samples will be collected to evaluate the immune status of these patients.
- Serum cytokine profiles
- Whole blood samples - lymphocyte sub-populations from fresh, refrigerated whole blood samples. Whole blood samples will be used to extract DNA and RNA material. The remaining DNA for future research related to cytokine gene and vitamin D receptor single nucleotide polymorphisms studies of the Molecular Epidemiology Laboratory
- H & E slides will be evaluated by our collaborating pathologist to validate diagnoses and Breslow thickness
- Formalin-fixed paraffin embedded blocks will be sectioned and stained for immunohistochemistry
- One slide will be prepared from the skin block to evaluate the presence of solar elastosis in relation to UV exposure
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): NCT00996827
|United States, New Mexico|
|Lovelace Women's Hospial|
|Albuquerque, New Mexico, United States, 87109|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Montasur Shaheen, MD||University of New Mexico|
|Study Chair:||Marianne Berwick, PhD||University of New Mexico Cancer Center|