UnknownNot Applicable

Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration

United States385 participantsStarted 2009-02-20

Plain-language summary

RATIONALE: Studying samples of blood and breast tissue from healthy women in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to breast cancer risk. PURPOSE: This research study is looking at breast tissue in women not previously diagnosed with breast cancer who are undergoing fine-needle aspiration.

Who can participate

Age range

35 Years – 60 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: * Women meeting one of the following requirements: * Regularly cycling premenopausal women under 45 years of age * Perimenopausal women 45-55 years of age who have had ≥ two periods in the past 6 months * Postmenopausal women under 60 years of age (no menstrual period for 12 months and follicle-stimulating hormone (FSH) levels \> 25 IU/dL) * No history of breast cancer diagnosis or prior treatment for breast cancer * Negative breast evaluation within the past 3 months PATIENT CHARACTERISTICS: * See Disease Characteristics PRIOR CONCURRENT THERAPY: * No concurrent oral contraceptives * At least 2 weeks since prior aspirin, non-steroidal anti-inflammatory drugs, and vitamin E

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

Differences in DNA methylation profiles between women in different menstrual stages

Timeframe: One time rFNA procedure to collect samples.

Differences in DNA methylation profiles between women in different menstrual stages

Timeframe: One time rFNA procedure to collect samples

Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate

Timeframe: One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.

Trial details

NCT IDNCT00896636

SponsorNorthwestern University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-01-18

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

35 Years – 60 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.

What they're measuring

Differences in DNA methylation profiles between women in different menstrual stages

Timeframe: One time rFNA procedure to collect samples.

Differences in DNA methylation profiles between women in different menstrual stages

Timeframe: One time rFNA procedure to collect samples

Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate

Timeframe: One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.