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临床试验/NCT05641012
NCT05641012尚未招募不适用

Association Between Helioderma and Response to Immunotherapy in Patients With Metastatic Melanoma

Institut Jean-Godinot0 个研究点目标入组 100 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Helioderma

研究概览

简要总结

Melanoma is one of the most aggressive forms of skin cancer, representing only 5% of all skin cancer but 80% of all death by skin cancer. Diagnosis and treatment of melanoma must be early because prognosis depends on stage disease.

Immunotherapy is used in metastatic melanoma. However, all patients not respond to immunotherapy.

Helioderma (photoaging) is a marker of exposure to UV rays and therefore of mutagenesis. Thus, helioderma could be associated with the response to immunotherapy.

详细描述

The detection and management of melanomas must be very early because the prognosis largely depends on the extent of the disease at the time of diagnosis.

For patients with melanoma, immunotherapy or dual therapy is used as treatment in unresectable and metastatic (AJCC stage IV) cases, depending on mutation status. Primary immunotherapy is possible in mutated patients in the absence of threatening progression.

However, not all patients respond well to immunotherapy, so biomarkers that predict treatment response are needed to optimize patient benefit.

The onset, development, and course of melanoma are based on the accumulation of genomic changes, including high loads of ultraviolet-induced mutations, which make melanoma the most immunogenic tumor. In several tumor types, tumor mutation load (TMB) and immune infiltration have been reported to predict response to immunotherapy. Indeed, the higher the TMB, the more the tumor is likely to produce a neo-tumor antigen, target of the reactivation of the immune system.

No threshold value of TMB has been determined to date, having a predictive value in melanoma. The degree of helioderma could be a potentially discriminating marker of the degree of UV exposure and therefore of mutagenesis. Preliminary results have reported the interest of this approach but must be confirmed because it was a small study (Russo et al).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • metastatic melanoma
  • Whatever the mutation BRAF status
  • treated by immunotherapy or specific therapy
  • aged more than 18
  • agreeing to participate to the study

排除标准

  • Patient whose treatment by immunotherapy has already started
  • Patient who have had a radiotherapy or chemotherapy treatment
  • Patient with an unknown primary melanoma, choroidal melanoma
  • Patient with other cancer (except basal cell and squamous cell skin cancer)
  • Patient with genetic predisposition for melanoma
  • aged less than 18
  • Adult not agreeing to participate to the study

结局指标

主要结局

Helioderma

时间窗: Day 0

Helioderma (photoageing) evaluated around the resection scar or melanoma (if no resection) by descriptive scale ranging from 0 to 3 (3 corresponding to strong helioderma): * 0: no sign * 1: actinic lentigo, wrinkles, telangiectasia, loss of laxity, thinning * 2: thick, yellowish and/or dry skin, deep wrinkles, irregular pigmentation (hyper-hypopigmented spots) * 3: actinic keratosis, basal cell carcinoma, squamous cell carcinoma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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