CompletedNot Applicable

Studying Cells Collected Through Ductal Lavage in Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer

30 participantsStarted 2004-04

Plain-language summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is evaluating cells collected through ductal lavage in women undergoing surgery for ductal carcinoma in situ or other breast cancer.

Who can participate

Age range

120 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: * Agrees to undergo breast surgical procedure AND meets one of the following criteria: * Scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings * Diagnosis of ductal carcinoma in situ (DCIS) or carcinoma in the breast to be studied (opposite breast may also be studied) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Pre- or post-menopausal * Not currently pregnant or pregnant within the past 12 months * Must not have lactated within the past 12 months * No active infection or inflammation in the breast to be studied * No known allergy to lidocaine, prilocaine, or marcaine (bupivacaine) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied * No prior breast implant that disrupts the ductal architecture in the breast to be studied * No prior silicone injections in the breast to be studied * No prior radiotherapy to the breast to be studied * No chemotherapy within the past 6 months * Concurrent prophylactic chemotherapy allowed * No concurrent participation in another research study that may conflict with or affect the outcome of this study

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

Expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures

Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in primary DCIS cell cultures

Expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage

Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in cells obtained by breast ductal lavage

Trial details

NCT IDNCT00896857

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2008-02

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