Protocol for Women at Increased Risk of Developing Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00291096|
Recruitment Status : Recruiting
First Posted : February 13, 2006
Last Update Posted : January 17, 2018
|Condition or disease|
- 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|
|Official Title:||High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer|
|Study Start Date :||January 1989|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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
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.||email@example.com|
|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|