- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860481
FSH-R : Diagnostic Application for Localized Tumors in Cancerology (FRACTal)
FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75005
- Institut Curie
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Saint Cloud, France, 92210
- Centre René Huguenin
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
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Other: second cohort : 100 patients
Patients with breast cancer of with ovarian and/or endometrial cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sensitivity of blood FSH R detection in cancer patients
Time Frame: end of the study, up to two years
|
end of the study, up to two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
variability of blood FSH-R in the same tumoral type and between different tumoral types
Time Frame: end of the study, up to two years
|
end of the study, up to two years
|
comparison of blood FSH-R with blood from healthy donor
Time Frame: end of the study, up to two years
|
end of the study, up to two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: François Clément Bidard, MD, Institut Curie
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IC 2012-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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