Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

Melanoma Clinical Trial

Official title:

Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00996827
• Other study ID #: INST 0815
• Status: Terminated
• Phase: N/A
• First received: October 14, 2009
• Last updated: June 17, 2015
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	Lovelace Women's Hospial	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	• Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients		1 year	No

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center