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Mapping the DNA test that decides who gets PARP inhibitors

NCT ID NCT07825181

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are reviewing medical records from about 1,125 women in Italy with newly diagnosed advanced high-grade epithelial ovarian cancer. The study focuses on how hospitals test tumors for homologous recombination deficiency (HRD), a DNA repair flaw that can make PARP inhibitor drugs more effective. The team will compare HRD results with patient characteristics and check which maintenance treatments doctors chose afterward. The goal is to describe real-world testing practices and how often HRD status shapes treatment decisions.

What this could mean

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

Active substance
HRD testing on tumor tissue samples
What this could lead to
If the study maps how HRD testing is done across Italy, it could help standardize which ovarian cancer patients get tested and how quickly results guide PARP inhibitor treatment.
What could go wrong
This is a retrospective record review, so it can only describe what already happened at seven centers. It cannot prove that any testing approach improves survival, and its findings may not apply to hospitals outside Italy.

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.

Participants

About 1,125 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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.

Who is studied

Eligible patients are those who underwent HRD testing at the participating centers (N=7) between January 2022 and December 2024, either at diagnosis in the case of FIGO stage III-IV disease, or at first metastatic recurrence if initially diagnosed at FIGO stage I-II. These centers were selected for their role as national referral hubs for ovarian cancer molecular diagnostics and are geographically distributed across Northern, Central, and Southern Italy, providing a representative overview of current HRD testing practices.

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: * Women ≥ 18 years old with a histological diagnosis of high grade epithelial ovarian cancer, serous or endometrioid histotype; * FIGO stage 2014 III-IV or at first metastatic recurrence if initially diagnosed at FIGO stage I-II; * HRD status assessed using SOPHiA DDMTM validated assays at each participating center Exclusion Criteria: * HRD assessment not performed in-house and/or other platforms; * clinical data not available; * laboratory data not available

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ovarian Epithelial ovarian carcinoma ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma

As listed by the trial registrant

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

Epithelial ovarian cancer

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Italy

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