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Trial Title:
Protocol for Women at Increased Risk of Developing Breast Cancer
NCT ID:
NCT00291096
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast atypia
fine needle aspiration
high risk for breast cancer
breast epithelial hyperplasia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The overall goal of this project is to develop an integrative system of breast cancer
risk assessment based on epidemiologic and biologic risk variables, as well as to develop
or refine risk biomarkers which may be useful in predicting and monitoring response to
prevention interventions.
Detailed description:
1. To correlate established risk biomarkers such as cytomorphology obtained from random
periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum
bioavailable estradiol and IGF-1/IGFBP-3 with each other and with 5-10 year Gail
risk estimates. Where available, and with appropriate safe guards to maintain status
for breast cancer susceptibility genes may be included.
2. To determine the relative predictive value of established risk biomarkers for the
development of DCIS and/or invasive cancer.
3. To evaluate potential new breast tissue-based biomarkers including Ki-67, PCNA, ER,
COX-2, aromatase, methylation of key tumor suppressor genes (i.e., RAR, p16, etc),
proteomic patterns in RPFNA and nipple aspirate fluid (NAF), as well as NAF hormone
levels, and correlate them with other risk biomarkers listed in 1.
4. To determine the prevalence of polymorphisms of a panel of genes important in
hormone and xenobiotic metabolism as well as DNA repair and correlate these
polymorphisms with established risk biomarkers listed in 1, as well as with
development of DCIS and invasive cancer.
5. To maintain contact with this initially identified cohort of high risk women,
acquire demographic data, biologic specimens and data and follow them prospectively
for the development.
Criteria for eligibility:
Study pop:
Self-identified women at high risk for development of breast cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- women with at least 2 times the normal risk of developing breast cancer
- between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first
degree relative)
- greater than six months from ingestion of antihormonal therapy
- greater than 1 year from pregnancy, lactation, or chemotherapy
- willing to have a mammogram within six months prior to RPFNA
- willing to discontinue NSAIDS or herbal supplements
- willing to have blood drawn
Exclusion Criteria:
- no metastatic malignancy of any kind
- no breast implants or tram flap reconstructions
- no radiation to both breasts
- no women who have a current mammogram or clinical breast exam suspicious for cancer
Gender:
Female
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Carol J Fabian, MD
Email:
Principal Investigator
Investigator:
Last name:
Bruce Kimler, PhD
Email:
Principal Investigator
Start date:
August 1989
Completion date:
December 2026
Lead sponsor:
Agency:
Carol Fabian, MD
Agency class:
Other
Source:
University of Kansas Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00291096
