Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer

NCT ID: NCT00041353

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2002-09-30

Brief Summary

RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment.

PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.

Detailed Description

OBJECTIVES:

• Compare specific biomarkers, including cellular morphology (cytology), proliferation index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer.
• Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting.
• Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer.
• Determine whether 1 or more biomarkers can distinguish high-risk from control patients.
• Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy.

OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. Specimens are analyzed for the presence of specific biomarkers.

PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: SCREENING

Interventions

cytology specimen collection procedure

Intervention Type: OTHER

comparison of screening methods

Intervention Type: PROCEDURE

study of high risk factors

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer OR a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast OR
• No increased risk of breast cancer as determined by a lack of the above conditions
• Scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump
• No prior bilateral mastectomy or bilateral breast irradiation
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 30 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No active invasive malignancy in any site except basal cell or squamous cell skin cancer
• No significant medical or psychiatric problems that would preclude study
• No evidence of excessive use of narcotics or drug dependency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H. Torosian, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Other Identifiers

CDR0000069491

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G02-2095

Identifier Type: -

Identifier Source: secondary_id

FCCC-02010

Identifier Type: -

Identifier Source: org_study_id