跳至主要内容
临床试验/NCT00996827
NCT00996827终止不适用

Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

New Mexico Cancer Care Alliance2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
2
主要终点
• 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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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,
  • 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

排除标准

  • 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.

结局指标

主要结局

• 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

时间窗: 1 year

次要结局

  • • Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验