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New study reveals how personalized breast cancer risk news impacts Women's emotions

NCT ID NCT04145817

Knowledge-focused Sponsor: Institut Curie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how women feel and think after getting a personalized estimate of their breast cancer risk. Researchers used a special computer model (BOADICEA) to give each woman a risk score based on her genes. The goal was to see if this personalized information changes how women perceive their risk and how they feel about it. 405 healthy women with a family history of breast cancer took part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

405 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy woman, relative of a family member first tested (index case) who received a positive genetic test result (presence of a BRCA1 or BRCA2 deleterious variant or a moderate-penetrance BC gene deleterious variant) ; a. at Cologne University Hospital (Germany), these healthy women may also be relatives of women (index case) who received a negative non-informative test result; 2. Who accept BRIDGES gene panel testing and the breast cancer risk PRS; 3. Aged 18 years or over with no upper limit; 4. Able to give informed written consent in accordance with national/local regulations and procedures; 5. Able to understand the questionnaire language of the participating genetic clinic. Exclusion Criteria: 1. Woman affected with BC, with recurrent BC, with metastatic BC, with an ovarian cancer (OC) or cancer of any other site; 2. Aged under 18 years old; 3. Unable to give informed written consent; 4. Unable to understand the questionnaire language of the participating clinic; 5. Unable to answer the questionnaire due to physical or cognitive disturbance

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Conditions

The condition(s) this trial relates to.

breast neoplasm inherited disease susceptibility ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genetic predisposition to disease

Contacts and locations

Locations

  • Institut Curie

    Paris, 75005, France

  • University Hospital of Cologne

    Cologne, 50923, Germany

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