Protocol for Women at Increased Risk of Developing Breast Cancer
Verified July 2014 by University of Kansas
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
First received: February 10, 2006
Last updated: July 25, 2014
Last verified: July 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
RPFNA specimens, serum, NAF
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2020 (Final data collection date for primary outcome measure)
- 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.
- To determine the relative predictive value of established risk biomarkers for the development of DCIS and/or invasive cancer.
- 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.
- 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.
- 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.
|Ages Eligible for Study:
||30 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Self-identified women at high risk for development of breast cancer
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291096
|University of Kansas Medical Center
|Kansas City, Kansas, United States, 66160 |
|Principal Investigator: Carol J Fabian, MD |
|Principal Investigator: Bruce Kimler, PhD |
Carol Fabian, MD
||Carol J Fabian, MD
||University of Kansas
No publications provided
||Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2006
||July 25, 2014
||United States: Institutional Review Board
Keywords provided by University of Kansas:
fine needle aspiration
high risk for breast cancer
breast epithelial hyperplasia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Neoplasms by Site