FSH-R : Diagnostic Application for Localized Tumors in Cancerology

Cancer Clinical Trial

— FRACTal  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02860481
• Other study ID #: IC 2012-09
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: April 13, 2017

Study information

• Verified date: July 2016
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• blood sample for FSHR analysis

• blood sample for FSHR analysis

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Centre René Huguenin	Saint Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of blood FSH R detection in cancer patients		end of the study, up to two years
Secondary	variability of blood FSH-R in the same tumoral type and between different tumoral types		end of the study, up to two years
Secondary	comparison of blood FSH-R with blood from healthy donor		end of the study, up to two years