- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291096
Protocol for Women at Increased Risk of Developing Breast Cancer
February 2, 2023 updated by: Carol Fabian, MD
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
- 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
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bruce Kimler, Ph.D.
- Phone Number: 913-588-4523
- Email: bkimler@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
Principal Investigator:
- Bruce Kimler, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Self-identified women at high risk for development of breast cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
ongoing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 1989
Primary Completion (ANTICIPATED)
December 1, 2025
Study Completion (ANTICIPATED)
December 1, 2026
Study Registration Dates
First Submitted
February 10, 2006
First Submitted That Met QC Criteria
February 10, 2006
First Posted (ESTIMATE)
February 13, 2006
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 2, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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