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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896636
First Posted: May 12, 2009
Last Update Posted: November 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
  Purpose

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.


Condition Intervention
Breast Cancer Healthy, no Evidence of Disease Procedure: Random fine need aspiration (rFNA) Other: Mammogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Differences in DNA methylation profiles between women in different menstrual stages [ Time Frame: One time rFNA procedure to collect samples. ]
  • Differences in DNA methylation profiles between women in different menstrual stages [ Time Frame: One time rFNA procedure to collect samples ]
  • Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate [ Time Frame: One time rFNA procedure to collect sample to compare with baseline mammogram and risk info. ]

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.

Enrollment: 385
Study Start Date: May 2008
Estimated Study Completion Date: September 2021
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Luteal
Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.
Procedure: Random fine need aspiration (rFNA)
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).
Other: Mammogram
Standard mammography of both breasts to obtain images for breast density measurement.
Follicular
Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.
Procedure: Random fine need aspiration (rFNA)
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).
Other: Mammogram
Standard mammography of both breasts to obtain images for breast density measurement.
Menopause
Women who have entered menopause.
Procedure: Random fine need aspiration (rFNA)
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).
Other: Mammogram
Standard mammography of both breasts to obtain images for breast density measurement.

Detailed Description:

OBJECTIVES:

Primary

  • To determine if breast tissue DNA methylation profile and hormone concentration change across follicular and luteal phase, or across menopause, in random fine needle aspiration samples of women with no prior diagnosis or treatment for breast cancer.
  • To determine if DNA methylation profile and breast hormone levels correlate with mammographic density, cytomorphology, or Gail risk estimates.
  • To develop a high throughput commercial assay for DNA methylation profiling for assessing breast cancer risk.
  • To develop a highly sensitive, specific, and novel nanoassay for estradiol and progesterone.

OUTLINE: This is a multicenter study.

Premenopausal women are stratified by menstrual cycle phase (mid-follicular [day 5-10] vs mid-luteal [day 20-25]), based on an adjusted 28-day cycle.

Patients undergo breast density measurement by digital mammography. Blood samples are obtained and analyzed for estradiol, progesterone, and follicle-stimulating hormone measurements, to define menstrual/menopausal status, and for DNA extraction. Patients also undergo random fine needle aspiration. Biopsy material from aspiration is analyzed for cytomorphology, steroid radioimmunoassay (RIA), steroid nanoassay, and DNA methylation studies (via polymerase chain reaction). The aspiration samples are also analyzed for estradiol and progesterone levels using high-pressure liquid chromatography and RIA.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896636


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00896636     History of Changes
Other Study ID Numbers: NU 08B2
P30CA060553 ( U.S. NIH Grant/Contract )
NU-08B2
NU-IRB-STU00003136
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: November 4, 2016
Last Verified: November 2016

Keywords provided by Northwestern University:
breast cancer
healthy, no evidence of disease

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases