FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- sensitivity of blood FSH R detection in cancer patients
研究概览
简要总结
FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the diagnosis of cancer.
A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will include n=10 patients per histological type except for breast cancer (n=50). 100 patients are expected in this cohort.
A second cohort will explore the more promising histological type (if any) in term of incidence of detection. 100 patients are expected for this second cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient diagnosed with localized cancer and corresponding to the different types explored. The cancer can be already diagnosed or not (strong suspicion)
- •Written informed consent
排除标准
- •Previous treatment for the tumoral disease
- •Personal history of cancer diagnosis in the last 10 years
- •Pregnant and/or breastfeeding women
- •Person deprived of liberty or under guardianship (including curatorship)
- •psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements
研究组 & 干预措施
first cohort : first 100 patients
first cohort : first 100 patients 10 patients with ovarian and/or endometrial cancer 10 patients with colorectal cancer 10 patients with head and neck cancer 10 patients with uveal melanoma 40 patients with invasive breast cancer 10 patients with breast ductal carcinoma in situ 10 patients with other tumor type
干预措施: blood sample for FSHR analysis (Procedure)
second cohort : 100 patients
Patients with breast cancer of with ovarian and/or endometrial cancer
干预措施: blood sample for FSHR analysis (Procedure)
结局指标
主要结局
sensitivity of blood FSH R detection in cancer patients
时间窗: end of the study, up to two years
次要结局
- variability of blood FSH-R in the same tumoral type and between different tumoral types(end of the study, up to two years)
- comparison of blood FSH-R with blood from healthy donor(end of the study, up to two years)