Viewing Study NCT00291096



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Study NCT ID: NCT00291096
Status: RECRUITING
Last Update Posted: 2023-02-06
First Post: 2006-02-10

Brief Title: Protocol for Women at Increased Risk of Developing Breast Cancer
Sponsor: Carol Fabian MD
Organization: University of Kansas Medical Center

Study Overview

Official Title: High Risk Breast Clinic Protocol for Women at Increased Risk for Developing Breast Cancer
Status: RECRUITING
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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-1IGFBP-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 andor 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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None