Breast CancerNCT00896636
Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration
An observational study of Breast Cancer and Healthy, no Evidence of Disease, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Healthy, no Evidence of Disease
- What is being tested?
- Random fine need aspiration (rFNA) and Mammogram
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2009to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk
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.
Read the 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.
- Conditions
- Breast Cancer, Healthy, no Evidence of Disease
- Being tested
- Random fine need aspiration (rFNA), Mammogram
- Keywords
- breast cancer, healthy, no evidence of disease
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Random fine need aspiration (rFNA)Procedure or surgery
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).
MammogramOther
Standard mammography of both breasts to obtain images for breast density measurement.
| Study group | Role | What they receive |
|---|---|---|
| Luteal | Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle. Receives: Procedure: Random fine need aspiration (rFNA); Other: Mammogram | |
| Follicular | Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle. Receives: Procedure: Random fine need aspiration (rFNA); Other: Mammogram | |
| Menopause | Women who have entered menopause. Receives: Procedure: Random fine need aspiration (rFNA); Other: Mammogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in DNA methylation profiles between women in different menstrual stages
Measured: One time rFNA procedure to collect samples.
Differences in DNA methylation profiles between women in different menstrual stages
Measured: One time rFNA procedure to collect samples
Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate
Measured: One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start20 Feb 2009
- Primary completion18 Jan 2013
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Seema A. Khan, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896636
- Sponsor's protocol ID
- NU 08B2
- Other IDs
- P30CA060553, NU-08B2, NU-IRB-STU00003136
- Status last verified
- Aug 2020
- First submitted
- 9 May 2009
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT00896636
- Acronym / sponsor ID
- NU 08B2
- Conditions
- Breast Cancer, Healthy, no Evidence of Disease
- Keywords
- breast cancer, healthy, no evidence of disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Feb 2009 (actual)
- Primary completion
- 18 Jan 2013 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Luteal | – | Procedure: Random fine need aspiration (rFNA), Other: MammogramPre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle. |
| Follicular | – | Procedure: Random fine need aspiration (rFNA), Other: MammogramPre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle. |
| Menopause | – | Procedure: Random fine need aspiration (rFNA), Other: MammogramWomen who have entered menopause. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Follicular, Luteal, Menopause |
| MammogramStandard mammography of both breasts to obtain images for breast density measurement. | Other | Follicular, Luteal, Menopause |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seema A. Khan, MD principal investigator
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Healthy, no Evidence of Disease, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in DNA methylation profiles between women in different menstrual stages (time frame: One time rFNA procedure to collect samples.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.