Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

This study has been terminated.
(Sufficient samples collected when 73% of target enrollment was reached.)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00996827
First received: October 14, 2009
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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
Melanoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: November 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have recieved interferon or IL-2 therapy.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996827

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Lovelace Women's Hospial
Albuquerque, New Mexico, United States, 87109
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Montasur Shaheen, MD University of New Mexico
Study Chair: Marianne Berwick, PhD University of New Mexico Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00996827     History of Changes
Other Study ID Numbers: INST 0815
Study First Received: October 14, 2009
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Melanoma
Skin cancer
Vitamin D
Vitamin D receptor
Sunlight
Cytokine

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 21, 2014