Clinical trial NCT00996827: Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma
Official title: Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Keywords: Melanoma
Skin cancer
Vitamin D
Vitamin D receptor
Sunlight
Cytokine
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have recieved interferon or IL-2 therapy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: • 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
timeFrame: 1 year
Secondary outcomes:
measure: • Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Lovelace Women's Hospial
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Montasur Shaheen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico Cancer Center
name: Marianne Berwick, PhD
role: STUDY_CHAIR
References: