Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

NCT00996827 | Terminated

• 1 other identifier: INST 0815
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma

Keywords

Melanoma; Skin cancer; Vitamin D; Vitamin D receptor; Sunlight; Cytokine

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (1)

• • Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients

  1 year

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have recieved interferon or IL-2 therapy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (2)

Lovelace Women's Hospial

Albuquerque, New Mexico, 87109, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Links

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

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

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Montasur Shaheen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Marianne Berwick, PhD

  University of New Mexico Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 16, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

US (2)