NCT05769517 (PROBE-II) is a clinical trial of Germinal BRCA in BRCA Mutation, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who is sponsoring NCT05769517?

NCT05769517 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT05769517?

Interventions in NCT05769517: Germinal BRCA.

What condition does NCT05769517 study?

NCT05769517 studies BRCA Mutation, Ovarian Cancer, Ultrasound Therapy; Complications.

Is NCT05769517 still recruiting?

NCT05769517 is currently recruiting now. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05769517: PROBE-II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

Recruiting now Last updated 13 April 2026

What this trial tests

trial testing Germinal BRCA in BRCA Mutation in 1,300 participants. Currently enrolling.

Timeline

20 March 2023

Primary endpoint
1 April 2024

8 March 2031

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,300
Start date	20 March 2023
Primary completion	1 April 2024
Estimated completion	8 March 2031
Sites	1 location across Italy

Drugs / interventions tested

Germinal BRCA

Conditions studied

BRCA Mutation — all drugs for BRCA Mutation →
Ovarian Cancer — all drugs for Ovarian Cancer →
Ultrasound Therapy; Complications — all drugs for Ultrasound Therapy; Complications →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Eligibility, female only, with BRCA Mutation or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Retrospective phase AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Prospective phase AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A cost-effectiveness analysis of an integrated clinical-radiogenomic screening program for the identification of BRCA 1/2 carriers (e-PROBE study).
Di Pilla A, Nero C, Specchia ML, Ciccarone F, et al · · 2024 · cited 6× · PMID 38195911 · DOI 10.1038/s41598-023-51031-1

Verify or expand the search:

Other recruiting trials for BRCA Mutation

Currently open trials in the same condition.

NCT06792721 — MEASUREMENT OF CIRCULATING MUTATION BURDEN · recruiting
NCT06666270 — Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT06497270 — A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial · NA · active not recruiting
NCT05485766 — Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer · Phase 2 · recruiting
NCT06177171 — Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors · Phase 1 · recruiting

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05769517 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05769517.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing