Clinical trial · Observational
Study of Ductal Lavage in Women at High Risk for Breast Cancer
Ductal Lavage to Monitor and Treat High Risk Women
NCT00429988CI-TRIAL-00008141completedClinicalTrials.gov clinicaltrialsProvenance
- 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: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high 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 |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| proteomic profiling | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Average number of atypical cells per ductal lavage sample
Secondary outcomes (4)
- measure
- Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis
- measure
- Specific and global protein signature analysis of nipple aspirate
- measure
- Replicability of markers in serial assays
- measure
- Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* High risk for breast cancer defined as 1 of the following:
* History of atypical hyperplasia or atypia found on biopsy, fine-needle aspiration, or ductal lavage
* Family history of cancer meeting at least 1 of the following criteria:
* Single relative with multiple primary cancers
* One or more relative under 40 years of age with breast cancer OR bilateral breast cancer
* Two or more relatives with ovarian cancer
* Two or more relatives with breast cancer and 1 is under 50 years of age
* One or more relative with breast cancer plus ≥ 1 relative with ovarian cancer
* Ashkenazi Jewish descent AND relative with breast cancer under 50 years of age OR ovarian cancer at any age
* BRCA1 and/or BRCA2 mutation
* Prior breast cancer in contralateral breast
* Gail risk \> 1.7%
* Spontaneous nipple discharge
* Serum estradiol \> 10 pmol/L
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* Over 18
Sex
* Female
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Able to obtain breast duct fluids
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 4 months since prior tamoxifen or raloxifene
Radiotherapy
* No prior radiotherapy to the breast
Surgery
* No prior incisional or excisional biopsy within 1.5 cm of nipple
Other
* No prior neoadjuvant therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.