Clinical trial · Interventional
Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment. PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast duct lavage | Procedure | — | UNRESOLVED |
| cytogenetic analysis | Genetic | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| proteomic profiling | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy
- measure
- Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling
- measure
- Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
- measure
- Comparison of cell yields vs final surgical pathology
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cellular atypia in nipple aspirate or ductal lavage fluid * Enrollment on RMNHS-2242 or RMNHS-2269 required * No inflammatory breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 to 64 Sex * Female Menopausal Status * Any status Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No prior allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine * No severe illness that would preclude study participation * No mental illness or handicap that would preclude study compliance * No active infection or inflammation in the breast being studied * No nursing within the past 12 months * Not pregnant * Not unconscious PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No prior tamoxifen Radiotherapy * Not specified Surgery * No prior subareolar surgery (e.g., papilloma resections, biopsies, or fine needle aspirations) or any other surgery that may disrupt the ductal systems within 2 cm of the nipple * Biopsies and fine needle aspirations \> 2 cm from the nipple are allowed * No prior breast implantation on proposed lavage side Other * No prior chemopreventative agents
References
Publications (0)
Data not yet available