Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

NCT00329017 | Withdrawn

• 1 other identifier: 9814
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.

  develoment of algorithm for prediction of risk of developing breast cancer.

  ongoing

Study Arms (1)

1

Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.

Procedure: Fine needle aspiration

Interventions

Fine needle aspiration PROCEDURE

Fine needle aspiration

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Carol Fabian, MD: lead
• Intergenetics, Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fine needle aspirate

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Carol J Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 24, 2006
• Study Start: May 1, 2005
• Primary Completion: November 12, 2015
• Study Completion: November 12, 2015
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)