Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Proportion of patients who have an oxidative profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))
研究概览
简要总结
Skin carcinomas are the most frequent cancers in the world, including basal cell carcinomas and cutaneous squamous cell carcinoma (cSCCs), with more than 60.000 new annual cases in France. Their incidence increases mainly due to ultraviolet (UV) exposure and population ageing. Then from 1994 to 2006, the incidence of cSCC has increased by 300%. CSCCs typically manifests as a spectrum from a precursor actinic keratosis (AK) - possible spontaneous regression at this stage- to in situ cSCC invasive cSCC and finally metastatic cSCC.
详细描述
Although growing evidence indicates that bioenergetic metabolism plays an important role in the progression of tumorigenesis, little information is available on the contribution of reprogramming of energy metabolism in cancer initiation and how it influences further the bioenergetic behavior of tumors.
By applying a quantitative proteomic approach, the consortium has recently found that specific metabolic modifications precede cSCC.
This study will investigate the role of energy metabolism in malignant transformation of premalignant skin lesions into cSCC, and in cSCC progression, with correlation with clinical characteristics and metastatic outcomes. Using several cutting-edge technologies in human samples, the team will evaluate whether targeting energy metabolism has the potential to be used as curative treatments for cSCC and whether pre-determined metabolic alterations could be exploited as new preventive strategies. These modifications in energy metabolism could be used as prognostic and diagnostic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Every patient with suspected lesion :
- •in situ cSCC,
- •infiltrative cSSC
- •cSCC with recurrent disease
- •cSCC with cutaneous metastases.
- •Patients 18 years of age or older,
- •Patients with suspected AK or BCC lesions (in situ, infiltrating or metastatic),
- •Patient able to sign a consent form,
- •Patient affiliated with a Social Security system.
排除标准
- •Prior systemic treatment such as checkpoint inhibitors or chemotherapy.
- •Patients with cSCC or AK localized on visible zone of the face or folds
研究组 & 干预措施
patients with squamous cell carcinomas
干预措施: biopsy (Other)
Patients with actinic keratoses
干预措施: biopsy (Other)
patients with squamous cell carcinoma in situ
干预措施: biopsy (Other)
patient with invasive metastates
干预措施: biopsy (Other)
结局指标
主要结局
Proportion of patients who have an oxidative profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))
时间窗: Day 1
Metabolic profiling of different stages of carcinogenesis: glycolysis, oxidative phosphorylation
Proportion of patients who have a glycolysis profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))
时间窗: Day 1
Metabolic profiling of different stages of carcinogenesis: glycolysis, oxidative phosphorylation
次要结局
- Evaluation of mitochondrial metabolism on skin biopsies(Day 1)
- Evaluation of skin differentiation markers(Day 1)
- Evaluation of cSCC aggressiveness markers(Day 1)
- Evaluation of cancer proliferative features on skin biopsies(Day 1)
- Evaluation of skin apoptotic markers(Day 1)