search
Back to results

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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cytology specimen collection procedure
comparison of screening methods
study of high risk factors
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, lobular breast carcinoma in situ

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2002
    Last Updated
    July 10, 2013
    Sponsor
    Fox Chase Cancer Center
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00041353
    Brief Title
    Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
    Official Title
    Breast Cancer Biomarkers Based on Fine Needle Aspirates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was not activated at Fox Chase Cancer Center
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    September 2002 (Actual)
    Study Completion Date
    September 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fox Chase Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    ductal breast carcinoma in situ, lobular breast carcinoma in situ

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    cytology specimen collection procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    comparison of screening methods
    Intervention Type
    Procedure
    Intervention Name(s)
    study of high risk factors

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael H. Torosian, MD
    Organizational Affiliation
    Fox Chase Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs