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Beyond BRCA: new gene panel could sharpen cancer risk prediction

NCT ID NCT03246841

Knowledge-focused Sponsor: UNICANCER 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study is investigating whether testing for a panel of 24 genes, in addition to the well-known BRCA1 and BRCA2 genes, can better estimate the risk of breast and ovarian cancer. Researchers will analyze genetic samples from people with a family history of these cancers, as well as their relatives, to see how mutations in these new genes affect cancer risk. The goal is to improve genetic counseling and screening for families at high risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Genetic testing for a panel of 24 genes associated with breast and ovarian cancer susceptibility
What this could lead to
If successful, this could lead to better identification of people at high risk for breast and ovarian cancer, enabling earlier screening and prevention strategies.
What could go wrong
The study is observational and may not directly lead to new treatments. The findings may not apply to all populations, and the clinical utility of the new gene panel is still uncertain.

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

7,274 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Index case eligibility: Any person with an indication for a BRCA1/BRCA2 gene analysis and who has been offered TUMOSPEC panel screening. Age ≥18 years. Family member eligibility: Family members will be eligible if the mutation identified in the Index Case is considered deleterious. Any family member to the first and second decree or a cousin of the Index Case. Family members from both sides of the family will be invited to take part. Age ≥18 years. Exclusion Criteria: People deprived of their civil liberties or who are under judicial protection or guardianship. Patients unable to answer the questionnaire for social or psychological reasons. Children of the index cases, of any age.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hereditary breast ovarian cancer syndrome ovarian cancer

As listed by the trial registrant

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

Hereditary breast and ovarian cancer Mutation

Contacts and locations

Locations

  • Gustave Roussy

    Paris, France

  • Institut Curie - PIGE

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.