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

Institut Curie

Status: Terminated

Conditions: Cancer

Treatments: Procedure: blood sample for FSHR analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02860481

IC 2012-09

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

first cohort : first 100 patients

Other group

Description:

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

Treatment:

Procedure: blood sample for FSHR analysis

Procedure: blood sample for FSHR analysis

second cohort : 100 patients

Other group

Description:

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

Treatment:

Procedure: blood sample for FSHR analysis

Procedure: blood sample for FSHR analysis