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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
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

Brief 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.

Condition or disease
Breast Cancer

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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
RPFNA specimens, serum, NAF

Information from the National Library of Medicine

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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
Study Population
Self-identified women at high risk for development of breast cancer

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

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): NCT00291096

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Contact: Bruce Kimler, Ph.D. 913-588-4523 bkimler@kumc.edu

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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         
Sponsors and Collaborators
Carol Fabian, MD
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Principal Investigator: Carol J Fabian, MD University of Kansas Medical Center
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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
Keywords provided by Carol Fabian, MD, University of Kansas Medical Center:
breast atypia
fine needle aspiration
high risk for breast cancer
breast epithelial hyperplasia
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases