COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

Condition or disease

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have recieved interferon or IL-2 therapy.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00996827

Layout table for location information
United States, New Mexico
Lovelace Women's Hospial
Albuquerque, New Mexico, United States, 87109
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Layout table for investigator information
Principal Investigator: Montasur Shaheen, MD University of New Mexico
Study Chair: Marianne Berwick, PhD University of New Mexico Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT00996827    
Other Study ID Numbers: INST 0815
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015
Keywords provided by New Mexico Cancer Care Alliance:
Skin cancer
Vitamin D
Vitamin D receptor
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas