Ovarian CarcinomaPhase 4PERSONA-OvaryNCT06972693
NGS-based Germline and Somatic Genetic Test in Ovarian Carcinoma
A Phase 4 study testing BRCA testing in people with Ovarian Carcinoma and Fallopian Tube Carcinoma, run by European Institute of Oncology at 1 site in Italy.
Trial summary
For patients with ovarian cancer and biologically related diseases, the implementation of genetic testing in the decision-making process could have an impact both on the risk management for the patient and his/her family, but also, more importantly, on the therapeutic management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- BRCA testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2018to 30 Dec 2025
- Phase
- Phase 4
- 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 18 or higher
- has signed informed consent
- histologically confirmed ovarian cancer, Fallopian tube cancer, or primary peritoneal cancer.
- Any stage is admitted
- Any histology is admitted
- availability of surgical/bioptic material. Formalin-fixed, paraffinembedded or frozen specimens are both allowed, with no time limitation
Who cannot join
- 1. unable or unwilling to receive genetic counseling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility of NGS-based Germline and Somatic Genetic Testing in Ovarian Carcinoma. The PERSONA-ovary Trial
For patients with ovarian cancer and biologically related diseases, the implementation of genetic testing in the decision-making process could have an impact both on the risk management for the patient and his/her family, but also, more importantly, on the therapeutic management.
The identification of genetically predisposed subjects can suggest risk reduction strategies that may involve bilateral salpingo-oophorectomy, mastectomy or long-term medical approaches. In the advanced setting, genetic testing may influence the decision for medical therapy (e.g. use of platinum derivatives or PARP inhibitors in patients with "BRCAness+" ovarian cancer).
Read more
The selection of patients for genetic testing has so far been restricted to patients with a strong family history of breast and ovarian cancer. It is now clear that the strict application of this criterion will result in a substantial number of people with a missed BRCA mutation.
Systematic large-scale genetic testing, simultaneously on germline and somatic tissues, is likely to improve decision-making algorithms in ovarian cancer patients. The feasibility of such an approach in the clinical setting, in terms of response times compatible with clinical needs and sensitivity comparable if not superior to single-gene tests, needs to be demonstrated before such diagnostic platforms can be routinely implemented in the diagnostic workflow.
This is the aim of the present study.
- Being tested
- BRCA testing
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRCA testingGenetic
BRCA 1 and 2 testing
| Study group | Role | What they receive |
|---|---|---|
| BRCA testing | Other | Not described Receives: Genetic: BRCA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of clinically relevant mutations in ovarian cancer riskassociated genes
evaluate prevalence of clinically relevant mutations in ovarian cancer risk associated genes
Measured: 3 months
Percentage of informative specimens
Percentage of informative specimens
Measured: 3 months
Genetic test turnaround time
Evaluate Genetic test turnaround time
Measured: 3 months
Secondary outcomes (5)
Incidence of all other mutations
Incidence of all other mutations
Measured: 3 months
progression-free survival
progression-free survival
Measured: 10 years
overall survival
overall survival
Measured: 10 years
Comparison of mutational profile across platforms: Devyser vs GerSom for BRC1/BRCA2
Comparison of mutation in BRC1/BRCA2 genes between Devyser vs GerSom platform
Measured: 3 months
Comparison of mutational profile across platforms: Trusight vs GerSom for all variants covered by both panels
Comparison of all gene mutations between Trusight and GerSom platform
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start12 Jun 2018
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective observational study
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972693
- Sponsor's protocol ID
- IEO 791
- Acronym
- PERSONA-Ovary
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of NGS-based Germline and Somatic Genetic Testing in Ovarian Carcinoma. The PERSONA-ovary Trial
- ClinicalTrials.gov ID
- NCT06972693
- Acronym / sponsor ID
- PERSONA-Ovary / IEO 791
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 323 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 May 2025 (actual)
- 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.
For patients with ovarian cancer and biologically related diseases, the implementation of genetic testing in the decision-making process could have an impact both on the risk management for the patient and his/her family, but also, more importantly, on the therapeutic management.
The identification of genetically predisposed subjects can suggest risk reduction strategies that may involve bilateral salpingo-oophorectomy, mastectomy or long-term medical approaches. In the advanced setting, genetic testing may influence the decision for medical therapy (e.g. use of platinum derivatives or PARP inhibitors in patients with "BRCAness+" ovarian cancer).
The selection of patients for genetic testing has so far been restricted to patients with a strong family history of breast and ovarian cancer. It is now clear that the strict application of this criterion will result in a substantial number of people with a missed BRCA mutation.
Systematic large-scale genetic testing, simultaneously on germline and somatic tissues, is likely to improve decision-making algorithms in ovarian cancer patients. The feasibility of such an approach in the clinical setting, in terms of response times compatible with clinical needs and sensitivity comparable if not superior to single-gene tests, needs to be demonstrated before such diagnostic platforms can be routinely implemented in the diagnostic workflow.
This is the aim of the present study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective observational study
| Arm | Type | Receives |
|---|---|---|
| BRCA testing | Other | Genetic: BRCA testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 or higher
- has signed informed consent
- histologically confirmed ovarian cancer, Fallopian tube cancer, or primary peritoneal cancer.
- Any stage is admitted
- Any histology is admitted
Key exclusion criteria (1 listed)
- 1. unable or unwilling to receive genetic counseling
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 |
|---|---|---|
| BRCA testingBRCA 1 and 2 testing | Genetic | BRCA testing |
Primary outcome
Prevalence of clinically relevant mutations in ovarian cancer riskassociated genes
Time frame: 3 months
evaluate prevalence of clinically relevant mutations in ovarian cancer risk associated genes
Percentage of informative specimens
Time frame: 3 months
Percentage of informative specimens
Genetic test turnaround time
Time frame: 3 months
Evaluate Genetic test turnaround time
5 secondary outcomes
Incidence of all other mutations
Time frame: 3 months
progression-free survival
Time frame: 10 years
overall survival
Time frame: 10 years
Comparison of mutational profile across platforms: Devyser vs GerSom for BRC1/BRCA2
Time frame: 3 months
Comparison of mutational profile across platforms: Trusight vs GerSom for all variants covered by both panels
Time frame: 3 months
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 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BRCA testing in people with Ovarian Carcinoma and Fallopian Tube Carcinoma, run by European Institute of Oncology at 1 site in Italy.
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 6 inclusion and 1 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of clinically relevant mutations in ovarian cancer riskassociated genes (time frame: 3 months). The study lists 3 primary outcomes in all. 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 May 2025.