Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

Terminated

• Conditions: Melanoma

• Registration Number: NCT00996827
• Lead Sponsor: New Mexico Cancer Care Alliance

Brief Summary

This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.

Detailed Description

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Resident of New Mexico
• Age between the 1 and 95
• Newly diagnosed with cutaneous invasive melanoma; any stage permitted (ICDO C44.0-9) between September 1, 2008 and December 31, 2011.
• SSM (superficial spreading melanoma) and NM (nodular melanoma) histological subtypes are allowed
• Access to a telephone or be able to participate in a personal interview at the clinic
• Physically and mentally competent to complete a 1-hour telephone or personal interview

Exclusion Criteria

• Ocular melanoma, LMM (lentigo maligna melanoma) or ALM (acral lentigo melanoma), and mucosal melanoma cases.
• No access to a telephone or is not able to meet with the interviewer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• 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	1 year

Secondary Outcome Measures

Name	Time	Method
• Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients	1 year

Trial Locations

Locations (2)

Lovelace Women's Hospial; 🇺🇸 Albuquerque, New Mexico, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States