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Protocol to Examine Methylation of Tumor Suppression Genes in Women at High Risk of Developing Breast Cancer

QM-MSP, Ki-67, and Cytomorphology of RPFNA Specimens From High Risk Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00323908
Enrollment
281
Registered
2006-05-10
Start date
2005-06-30
Completion date
2008-11-30
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, prevention, tissue sampling, polymorphisms, steroid and carcinogen metabolism

Brief summary

A study to examine the correlations between methylation of various genes associated with breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by random periareolar fine needle aspiration of women at high risk for development of breast cancer.

Detailed description

A study to examine the correlation between gene promotor methylation and benign breast tissue proliferation and cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer.

Interventions

None listed

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
Avon Foundation
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Johns Hopkins University
CollaboratorOTHER
Carol Fabian, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* women at high risk of developing breast cancer determined by family or personal history * willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion criteria

* exclude women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026