Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoin… (NCT00083018) | Clinical Trial Compass
UnknownPhase 2
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
United Kingdom100 participantsStarted 2003-09
Plain-language summary
RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment.
PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* No metastatic disease
* No inflammatory breast cancer
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No active infection or inflammation in the breast under study
* No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
* No severe illness
* Not unconscious
* No mental illness or handicap
* No nursing within the past 12 months
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* No prior breast implantation on side of proposed lavage
* No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings
2
Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells
3
Comparison of cell yields vs final surgical pathology of the operative specimens