NCT06972693

NGS-based Germline and Somatic Genetic Test in Ovarian Carcinoma

Evaluating the Feasibility of NGS-based Germline and Somatic Genetic Testing in Ovarian Carcinoma. The PERSONA-ovary Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Ovarian Carcinoma
• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
GENETIC	BRCA testing	BRCA 1 and 2 testing

Timeline

• Start date: 2018-06-12
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: Italy