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ACTIVE NOT RECRUITING
NCT06972693
PHASE4

NGS-based Germline and Somatic Genetic Test in Ovarian Carcinoma

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

323

Start Date

2018-06-12

Completion Date

2025-12-30

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

GENETIC

BRCA testing

BRCA 1 and 2 testing

Locations (1)

Istituto Europeo di Oncologia

Milan, Italy, Italy