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NCT07428733
Gene Methylation for Diagnosis of Breast Lesions
NA trial testing Gene Methylation Analysis of BRCA1, RASSF1A and PTEN in Breast Lesions of Uncertain Malignant Potential in 401 participants. Completed in 9 January 2026.
31 December 2025
Quick facts
| Lead sponsor | Institute of Oncology Ljubljana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 401 |
| Start date | 1 September 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 9 January 2026 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- Gene Methylation Analysis of BRCA1, RASSF1A and PTEN
Conditions studied
- Breast Lesions of Uncertain Malignant Potential — all drugs for Breast Lesions of Uncertain Malignant Potential →
- PTEN — all drugs for PTEN →
Sponsor
Institute of Oncology Ljubljana
Who can join
18 and older, female only, with Breast Lesions of Uncertain Malignant Potential or PTEN. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast lesions of uncertain malignant potential represent a diagnostic challenge, as conventional histopathological assessment does not always reliably distinguish between benign and malignant changes. The purpose of this prospective diagnostic study is to evaluate whether methylation patterns of selected breast cancer-related genes (BRCA1, RASSF1A, and PTEN) can help differentiate benign from malignant breast lesions. Tissue samples obtained during diagnostic needle biopsy, and when applicable during surgical excision, will be analyzed for gene methylation status. The results will be compared with standard histopathological findings. The study aims to improve diagnostic accuracy in breast lesions of uncertain malignant potential and contribute to better clinical decision-making in breast diagnostics.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07428733
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Institute of Oncology Ljubljana trials
Trials by the same sponsor.
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- NCT07432399 — Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study) · Phase 2 · recruiting
- NCT06650423 — Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer · recruiting
- NCT07420647 — Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Cancer Treatment · NA · active not recruiting
- NCT07416500 — BRCA1, RASSF1A and PTEN Methylation in Breast Lesions of Uncertain Malignant Potential · NA · completed
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 NCT07428733 (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 Institute of Oncology Ljubljana
- Last refreshed: 24 February 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/NCT07428733.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing