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Women at Risk of Breast Cancer and OLFM4

Primary Purpose

Hereditary Breast and Ovarian Cancer Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OLFM4
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hereditary Breast and Ovarian Cancer Syndrome focused on measuring High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > or = 18 years

  • High risk women of breast cancer occurrence defined by the following criteria:

    • Women carrying a genetic mutation BRCA1 or 2 or TP53, entering or already in screening breast IRM
    • Women with a high probability of hereditary predisposition to breast cancer (20% risk at 70 years of breast cancer by BOADICEA model), assessed by the onco-geneticists
  • Information of the person and signing the informed consent

Exclusion Criteria:

  • Women with a history of breast cancer or in situ
  • Person who is not affiliated to a social security scheme or beneficiary of such a regime

Sites / Locations

  • Institut de Cancerologie de l'Ouest
  • CHU Morvan
  • CHRecruiting
  • CH
  • Instit de Cancérologie de l'Ouest
  • CHU La Mileterie
  • CHU Bretonneau
  • CHBA Hopital Chubert

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OLFM4

Arm Description

Patient have a blood test every 6 months at the same time of the clinical exam planned in the following. The OLFM4 will be dose in the blood sample and the rate of OLFM4 compared to the result of imaging.

Outcomes

Primary Outcome Measures

The OLFM4 rate will be dosing by ELISA test in initial and followed blood sample of patient. This rate will be compared to the imaging to determine the positive predictive value of the assay OLFM4

Secondary Outcome Measures

The OLFM4 rate will be dosing by ELISA test in initial and followed blood sample of patient. This rate will be compared to the histology when it's possible.

Full Information

First Posted
January 8, 2016
Last Updated
March 23, 2020
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT02653105
Brief Title
Women at Risk of Breast Cancer and OLFM4
Official Title
Evaluation of the Circulating Concentration of Olfactomédine 4 (OLFM4) in Women With a BRCA1 or 2 Gene Mutation or at High Risk of Developing Breast Cancer, According to the Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?
Detailed Description
About 5% of breast cancers are associated with the presence of a constitutional genetic alteration. Two genes are being studied: BRCA1 and BRCA2. The national program for breast cancer screening target women 50 to 74 years but does not include women with significant risk factors. However in identifiable risk situations, breast cancer incidence is increased: and it affects 1 in 4 women with certain risk histological lesions and more than 1 in 2 women carrying a mutation in the BRCA1 or BRCA2 gene. Studies have shown that the olfactomédine 4 (OLFM4) is highly overexpressed in tumors compared to healthy tissue. The OLFM4 might therefore be a marker for early detection of breast cancer. We wish to determine the positive predictive value of OLFM4 seric dosing of patients at risk with respect to imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast and Ovarian Cancer Syndrome
Keywords
High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OLFM4
Arm Type
Experimental
Arm Description
Patient have a blood test every 6 months at the same time of the clinical exam planned in the following. The OLFM4 will be dose in the blood sample and the rate of OLFM4 compared to the result of imaging.
Intervention Type
Biological
Intervention Name(s)
OLFM4
Intervention Description
patient have an additional blood test every 6 months for dosing OLFM4
Primary Outcome Measure Information:
Title
The OLFM4 rate will be dosing by ELISA test in initial and followed blood sample of patient. This rate will be compared to the imaging to determine the positive predictive value of the assay OLFM4
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The OLFM4 rate will be dosing by ELISA test in initial and followed blood sample of patient. This rate will be compared to the histology when it's possible.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > or = 18 years High risk women of breast cancer occurrence defined by the following criteria: Women carrying a genetic mutation BRCA1 or 2 or TP53, entering or already in screening breast IRM Women with a high probability of hereditary predisposition to breast cancer (20% risk at 70 years of breast cancer by BOADICEA model), assessed by the onco-geneticists Information of the person and signing the informed consent Exclusion Criteria: Women with a history of breast cancer or in situ Person who is not affiliated to a social security scheme or beneficiary of such a regime
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali BALAVOINE
Phone
2 41 35 29 31
Ext
00 33
Email
magali.balavoine@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
François PEIN, MD
Phone
2 40 67 99 08
Ext
00 33
Email
francois.pein@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paule AUGEREAU, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest - ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paule AUGEREAU, MD
Email
paule.augereau@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Paule AUGEREAU, MD
Facility Name
CHU Morvan
City
Brest
ZIP/Postal Code
29000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Séverine AUDEBERT-BELLANGER, MD
Email
severine.audebert@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Séverine AUDEBERT-BELLANGER, MD
Facility Name
CH
City
Cholet
ZIP/Postal Code
49300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier INGSTER, MD
Email
olivier.ingster@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Olivier INGSTER, MD
Facility Name
CH
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier INGSTER, MD
Email
olivier.ingster@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Olivier INGSTER, MD
Facility Name
Instit de Cancérologie de l'Ouest
City
Nantes
ZIP/Postal Code
44805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Capucine DELNATTE, MD
First Name & Middle Initial & Last Name & Degree
Capucine DELNATTE, MD
Facility Name
CHU La Mileterie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte GILBERT-DUSSARDIER, MD, PhD
Email
brigitte.gibert-dussardier@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Brigitte GIBERT-DUSSARDIER, MD, PhD
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle MORTEMOUSQUE, MD
Email
i.mortemousque@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Isabelle MORTEMOUSQUE, MD
Facility Name
CHBA Hopital Chubert
City
Vannes
ZIP/Postal Code
56000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert JOURNEL, MD
Email
hubert.journel@ch-bretagne-atlantique.fr
First Name & Middle Initial & Last Name & Degree
Hubert JOURNEL, MD

12. IPD Sharing Statement

Learn more about this trial

Women at Risk of Breast Cancer and OLFM4

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