FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Institut Curie
- Enrollment
- 95
- Locations
- 2
- Primary Endpoint
- sensitivity of blood FSH R detection in cancer patients
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Arms & Interventions
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
Intervention: blood sample for FSHR analysis (Procedure)
second cohort : 100 patients
Patients with breast cancer of with ovarian and/or endometrial cancer
Intervention: blood sample for FSHR analysis (Procedure)
Outcomes
Primary Outcomes
sensitivity of blood FSH R detection in cancer patients
Time Frame: end of the study, up to two years
Secondary Outcomes
- 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)