Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

NCT ID: NCT00996827

Last Updated: 2015-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Melanoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Montasur Shaheen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Marianne Berwick, PhD

Role: STUDY_CHAIR

University of New Mexico Cancer Center

Locations

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Lovelace Women's Hospial

Albuquerque, New Mexico, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Related Links

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http://www.cancer.unm.edu

University of New Mexico Cancer Center

http://www.nmcca.org

New Mexico Cancer Care Alliance

Other Identifiers

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INST 0815

Identifier Type: -

Identifier Source: org_study_id

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