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

NCT00896636 | Unknown DMC

• 4 other identifiers: NU 08B2P30CA060553NU-08B2NU-IRB-STU00003136
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Healthy, no Evidence of Disease

Keywords

breast cancer; healthy, no evidence of disease

Outcome Measures

Primary Outcomes (3)

• Differences in DNA methylation profiles between women in different menstrual stages

  One time rFNA procedure to collect samples.

• Differences in DNA methylation profiles between women in different menstrual stages

  One time rFNA procedure to collect samples

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

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

Study Arms (3)

Luteal

Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.

Procedure: Random fine need aspiration (rFNA); Other: Mammogram

Follicular

Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.

Procedure: Random fine need aspiration (rFNA); Other: Mammogram

Menopause

Women who have entered menopause.

Procedure: Random fine need aspiration (rFNA); Other: Mammogram

Interventions

Random fine need aspiration (rFNA) PROCEDURE

Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).

Follicular; Luteal; Menopause

Mammogram OTHER

Standard mammography of both breasts to obtain images for breast density measurement.

Follicular; Luteal; Menopause

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women coming in for screening mammography, for diagnostic imaging, for evaluation of benign breast problems, and for breast cancer risk evaluation who have no history of breast cancer.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast tissue random fine needle aspiration (rFNA) samples will be collected and levels of methylation and hormones will be measured in each.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seema A. Khan, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: February 20, 2009
• Primary Completion: January 18, 2013
• Study Completion: January 1, 2022
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

US (1)