Protocol for Women at Increased Risk of Developing Breast Cancer
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ClinicalTrials.gov Identifier: NCT00291096 |
Recruitment Status :
Recruiting
First Posted : February 13, 2006
Last Update Posted : October 25, 2021
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Condition or disease |
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Breast Cancer |
- 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.
Study Type : | Observational |
Estimated Enrollment : | 3000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer |
Actual Study Start Date : | August 1989 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2026 |

- Prediction of risk for developing breast cancer [ Time Frame: ongoing ]development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

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): NCT00291096
Contact: Bruce Kimler, Ph.D. | 913-588-4523 | bkimler@kumc.edu |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Principal Investigator: Carol J Fabian, MD | |
Principal Investigator: Bruce Kimler, PhD |
Principal Investigator: | Carol J Fabian, MD | University of Kansas Medical Center |
Responsible Party: | Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT00291096 |
Other Study ID Numbers: |
4601 |
First Posted: | February 13, 2006 Key Record Dates |
Last Update Posted: | October 25, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
breast atypia fine needle aspiration high risk for breast cancer breast epithelial hyperplasia |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |