FSH-R : Diagnostic Application for Localized Tumors in Cancerology

NCT ID: NCT02860481

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-04-13

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

blood sample for FSHR analysis

Intervention Type PROCEDURE

second cohort : 100 patients

Patients with breast cancer of with ovarian and/or endometrial cancer

Group Type OTHER

blood sample for FSHR analysis

Intervention Type PROCEDURE

Interventions

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blood sample for FSHR analysis

Intervention Type PROCEDURE

blood sample for FSHR analysis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Clément Bidard, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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Institut Curie

Paris, , France

Site Status

Centre René Huguenin

Saint-Cloud, , France

Site Status

Countries

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France

Other Identifiers

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IC 2012-09

Identifier Type: -

Identifier Source: org_study_id

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