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

This study has been withdrawn prior to enrollment.
(Study was not activated at Fox Chase Cancer Center)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00041353
First received: July 8, 2002
Last updated: July 10, 2013
Last verified: July 2013

July 8, 2002
July 10, 2013
Not Provided
September 2002   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00041353 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
Breast Cancer Biomarkers Based on Fine Needle Aspirates

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.

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.

Interventional
Not Provided
Primary Purpose: Screening
Breast Cancer
  • Other: cytology specimen collection procedure
  • Procedure: comparison of screening methods
  • Procedure: study of high risk factors
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2002
September 2002   (final data collection date for primary outcome measure)

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
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00041353
FCCC-02010, CDR0000069491, NCI-G02-2095
No
Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael H. Torosian, MD Fox Chase Cancer Center
Fox Chase Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP