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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041353
Recruitment Status : Withdrawn (Study was not activated at Fox Chase Cancer Center)
First Posted : May 26, 2003
Last Update Posted : July 11, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

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
Breast Cancer Other: cytology specimen collection procedure Procedure: comparison of screening methods Procedure: study of high risk factors Not Applicable

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Screening
Official Title: Breast Cancer Biomarkers Based on Fine Needle Aspirates
Actual Primary Completion Date : September 2002
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 30 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00041353

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael H. Torosian, MD Fox Chase Cancer Center

Responsible Party: Fox Chase Cancer Center Identifier: NCT00041353     History of Changes
Other Study ID Numbers: FCCC-02010
CDR0000069491 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 26, 2003    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Fox Chase Cancer Center:
ductal breast carcinoma in situ
lobular breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases