Hereditary Breast and Ovarian Cancer SyndromeNCT02653105
Women at Risk of Breast Cancer and OLFM4
A study testing OLFM4 in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Institut Cancerologie de l'Ouest at 4 sites in France.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- OLFM4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Mar 2016to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Institut de Cancerologie de l'Ouest
Angers, 49055
CHU Morvan
Brest, 29000
Instit de Cancérologie de l'Ouest
Nantes, 44805
CHBA Hopital Chubert
Vannes, 56000
About this study
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
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?
Read the 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.
- Being tested
- OLFM4
- Keywords
- High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLFM4Biological
patient have an additional blood test every 6 months for dosing OLFM4
| Study group | Role | What they receive |
|---|---|---|
| OLFM4 | Experimental | 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. Receives: Biological: OLFM4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of circulating OLFM4 in BRCA1/2 mutation carriers or high-risk women with positive breast imaging
The primary objective is to determine the positive predictive value of serum OLFM4 levels in women who are BRCA1 or BRCA2 mutation carriers, or considered at high risk for breast cancer, and who present with a positive imaging workup (including MRI, mammography, and ultrasound) leading to biopsy. The study aims to assess whether OLFM4 can help reduce false positives from imaging and thereby limit unnecessary biopsies. Blood samples will be collected every 6 months over a 10-year period.
Measured: Every 6 months, up to 10 years (120 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start8 Mar 2016
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Breast and Ovarian Cancer SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paule AUGEREAU, MD, Principal investigator, Institut de Cancérologie de l'Ouest - ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653105
- Sponsor's protocol ID
- ICO-A-2014-05
- Other IDs
- 2014-A00305-42
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2016
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02653105
- Acronym / sponsor ID
- ICO-A-2014-05
- Keywords
- High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLFM4 | Experimental | Biological: OLFM4Patient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > or = 18 years
- High risk women of breast cancer occurrence defined by the following criteria:
- Information of the person and signing the informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLFM4patient have an additional blood test every 6 months for dosing OLFM4 | Biological | OLFM4 |
Primary outcome
Predictive value of circulating OLFM4 in BRCA1/2 mutation carriers or high-risk women with positive breast imaging
Time frame: Every 6 months, up to 10 years (120 months)
The primary objective is to determine the positive predictive value of serum OLFM4 levels in women who are BRCA1 or BRCA2 mutation carriers, or considered at high risk for breast cancer, and who present with a positive imaging workup (including MRI, mammography, and ultrasound) leading to biopsy. The study aims to assess whether OLFM4 can help reduce false positives from imaging and thereby limit unnecessary biopsies. Blood samples will be collected every 6 months over a 10-year period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paule AUGEREAU, MD principal investigator
Institut de Cancérologie de l'Ouest - ANGERS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLFM4 in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Institut Cancerologie de l'Ouest at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of circulating OLFM4 in BRCA1/2 mutation carriers or high-risk women with positive breast imaging (time frame: Every 6 months, up to 10 years (120 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.