FSH-R : Diagnostic Application for Localized Tumors in Cancerology

NCT02860481 | Terminated

• 1 other identifier: IC 2012-09
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• sensitivity of blood FSH R detection in cancer patients

  end of the study, up to two years

Secondary Outcomes (2)

• 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

Study Arms (2)

first cohort : first 100 patients

OTHER

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

second cohort : 100 patients

OTHER

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

Procedure: blood sample for FSHR analysis

Interventions

blood sample for FSHR analysis PROCEDURE

first cohort : first 100 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (2)

Institut Curie

Paris, 75005, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François Clément Bidard, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 9, 2016
• Study Start: November 1, 2013
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: August 24, 2023

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)