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

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00041353
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cytology specimen collection procedure
  • Procedure: comparison of screening methods
  • Procedure: study of high risk factors
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Primary Purpose:
Screening
Official Title:
Breast Cancer Biomarkers Based on Fine Needle Aspirates
Actual Primary Completion Date :
Sep 1, 2002
Actual Study Completion Date :
Sep 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fox Chase Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Michael H. Torosian, MD, Fox Chase Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fox Chase Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00041353
    Other Study ID Numbers:
    • FCCC-02010
    • CDR0000069491
    • NCI-G02-2095
    First Posted:
    May 26, 2003
    Last Update Posted:
    Jul 11, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Fox Chase Cancer Center
    ductal breast carcinoma in situ
    lobular breast carcinoma in situ
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 11, 2013