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BRCA1, RASSF1A and PTEN Methylation in Breast Lesions of Uncertain Malignant Potential

NCT07416500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2026-02-25

No results posted yet for this study

Summary

This prospective interventional diagnostic study evaluates the clinical utility of methylation analysis of BRCA1, RASSF1A and PTEN genes in breast lesions of uncertain malignant potential (B3 lesions).

Women with suspicious non-palpable breast lesions undergo standard diagnostic procedures including clinical examination, imaging assessment, and image-guided core needle biopsy when indicated.

As part of the study protocol, breast tissue samples are prospectively assigned to additional molecular diagnostic testing using methylation-specific multiplex ligation-dependent probe amplification (MS-MLPA).

The study evaluates whether gene promoter methylation status improves diagnostic assessment by comparing methylation results with final histopathological diagnosis.

Conditions

  • Breast Cancer
  • Breast Lesions of Uncertain Malignant Potential (B3 Lesions)

Interventions

DIAGNOSTIC_TEST

MS-MLPA Methylation Analysis

Methylation-specific multiplex ligation-dependent probe amplification (MS-MLPA) is performed on breast tissue samples obtained during routine diagnostic procedures. The assay determines promoter methylation status of BRCA1, RASSF1A and PTEN. Results are compared with the final histopathological diagnosis to evaluate diagnostic performance.

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416500 on ClinicalTrials.gov