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NCT07253051: BRCA_ENDORSE
BRCA Mutation Carriers' Platform a Multicenter Study
trial testing Registration of clinical datas in the platform in BRCA1 Mutation in 10,000 participants. Currently enrolling.
1 April 2045
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 10,000 |
| Start date | 5 April 2025 |
| Primary completion | 1 April 2045 |
| Estimated completion | 31 December 2045 |
| Sites | 40 locations across Italy |
Drugs / interventions tested
- Registration of clinical datas in the platform
Conditions studied
- BRCA1 Mutation — all drugs for BRCA1 Mutation →
- BRCA2 Mutation — all drugs for BRCA2 Mutation →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, female only, with BRCA1 Mutation or BRCA2 Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Subjects who carry mutations in breast cancer susceptibility genes 1 and 2 (BRCA1 and BRCA2 genes) are at higher risk of developing cancers. Despite the cumulative amount of evidence published in the literature in the last two decades, the management of BRCA mutation carriers is still not completely defined. Since the prevalence of the mutation is estimated to be 1:400 - 1:500 individuals, the total number of BRCA mutation carriers should be around 140.000 - 150.000 in the Italian population. It is estimated that 87% of women with BRCA mutations will experience, in their lifetime, a tumor with a genetic origin. About 20% of the 5200 ovarian cancer cases diagnosed each year in Italy has a genetic origin and could potentially be the object of primary prevention. To date, and to the best of our knowledge, a national prospective data collection on women with BRCA mutations has not been yet established.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07253051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for BRCA1 Mutation
Currently open trials in the same condition.
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- NCT06201234 — Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+ · Phase 2 · recruiting
- NCT06488378 — Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Brea · Phase 1 · recruiting
- NCT05485766 — Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer · Phase 2 · recruiting
- NCT06380660 — Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT07253051 (US National Library of Medicine, public domain)
- 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: 28 November 2025
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/NCT07253051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing