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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041353
First received: July 8, 2002
Last updated: February 6, 2009
Last verified: September 2002
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Other: cytology specimen collection procedure
Procedure: comparison of screening methods
Procedure: study of high risk factors

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Breast Cancer Biomarkers Based on Fine Needle Aspirates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041353

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00041353     History of Changes
Other Study ID Numbers: CDR0000069491, FCCC-02010, NCI-G02-2095
Study First Received: July 8, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
lobular breast carcinoma in situ

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

ClinicalTrials.gov processed this record on May 23, 2013