FSH-R : Diagnostic Application for Localized Tumors in Cancerology

Study Overview
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Brief Summary
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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.

Official Title
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FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology

Conditions
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Cancer

Intervention / Treatment
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* Procedure: blood sample for FSHR analysis
* Procedure: blood sample for FSHR analysis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patient diagnosed with localized cancer and corresponding to the different types explored. The cancer can be already diagnosed or not (strong suspicion) Age> 18 Written informed consent Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: first cohort : first 100 patients<br>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 | Procedure: blood sample for FSHR analysis<br> <br> |
| Other: second cohort : 100 patients<br>Patients with breast cancer of with ovarian and/or endometrial cancer | Procedure: blood sample for FSHR analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity of blood FSH R detection in cancer patients |  | end of the study, up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |