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FSH-R : Diagnostic Application for Localized Tumors in Cancerology

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02860481
Acronym
FRACTal
Enrollment
95
Registered
2016-08-09
Start date
2013-11-30
Completion date
2017-04-13
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

PROCEDUREblood sample for FSHR analysis

Sponsors

Institut Curie
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient diagnosed with localized cancer and corresponding to the different types explored. The cancer can be already diagnosed or not (strong suspicion) 2. Age\> 18 3. Written informed consent

Exclusion criteria

1. Previous treatment for the tumoral disease 2. Personal history of cancer diagnosis in the last 10 years 3. Pregnant and/or breastfeeding women 4. Person deprived of liberty or under guardianship (including curatorship) 5. psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements

Design outcomes

Primary

MeasureTime frame
sensitivity of blood FSH R detection in cancer patientsend of the study, up to two years

Secondary

MeasureTime frame
variability of blood FSH-R in the same tumoral type and between different tumoral typesend of the study, up to two years
comparison of blood FSH-R with blood from healthy donorend of the study, up to two years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026