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Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00329017
Enrollment
0
Registered
2006-05-24
Start date
2005-05-31
Completion date
2015-11-12
Last updated
2019-10-10

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

Conditions

Breast Cancer

Keywords

SNPs, single nucleotide polymorphism, breast atypia, breast epithelial hyperplasia, high risk for breast cancer

Brief summary

A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Detailed description

A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Interventions

Fine needle aspiration

Sponsors

Intergenetics, Inc.
CollaboratorINDUSTRY
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

* postmenopausal women on or off hormone replacement therapy * at high risk of developing breast cancer determined by family or personal history * postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration * willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.ongoingdeveloment of algorithm for prediction of risk of developing breast cancer.

Countries

United States

Outcome results

None listed

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