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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 : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date February 10, 2006
First Posted Date February 13, 2006
Last Update Posted Date December 31, 2020
Actual Study Start Date August 1989
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2015)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protocol for Women at Increased Risk of Developing Breast Cancer
Official Title High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
RPFNA specimens, serum, NAF
Sampling Method Non-Probability Sample
Study Population Self-identified women at high risk for development of breast cancer
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 31, 2007)
3000
Original Enrollment
 (submitted: February 10, 2006)
500
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Bruce Kimler, Ph.D. 913-588-4523 bkimler@kumc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00291096
Other Study ID Numbers 4601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Carol Fabian, MD, University of Kansas Medical Center
Study Sponsor Carol Fabian, MD
Collaborators Not Provided
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date December 2020