FSH-R : Diagnostic Application for Localized Tumors in Cancerology (FRACTal)

August 22, 2023 updated by: Institut Curie

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • Institut Curie
      • Saint Cloud, France, 92210
        • Centre Rene Huguenin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: blood sample for FSHR analysis
Other: second cohort : 100 patients
Patients with breast cancer of with ovarian and/or endometrial cancer
Procedure: blood sample for FSHR analysis

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

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: François Clément Bidard, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 13, 2017

Study Completion (Actual)

April 13, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimated)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

July 1, 2016

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)?

NO

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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