Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860481
Recruitment Status : Terminated (no inclusions)
First Posted : August 9, 2016
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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.


Condition or disease Intervention/treatment Phase
Cancer Procedure: blood sample for FSHR analysis Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology
Study Start Date : November 2013
Actual Primary Completion Date : April 13, 2017
Actual Study Completion Date : April 13, 2017

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



Primary Outcome Measures :
  1. sensitivity of blood FSH R detection in cancer patients [ Time Frame: end of the study, up to two years ]

Secondary Outcome Measures :
  1. 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 ]
  2. comparison of blood FSH-R with blood from healthy donor [ Time Frame: end of the study, up to two years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860481


Locations
Layout table for location information
France
Institut Curie
Paris, France, 75005
Centre René Huguenin
Saint Cloud, France, 92210
Sponsors and Collaborators
Institut Curie
Investigators
Layout table for investigator information
Principal Investigator: François Clément Bidard, MD Institut Curie

Layout table for additonal information
Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02860481     History of Changes
Other Study ID Numbers: IC 2012-09
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No