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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This study has been withdrawn prior to enrollment.
(Study was not activated at Fox Chase Cancer Center)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041353
First Posted: May 26, 2003
Last Update Posted: July 11, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center
  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:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 0
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00041353     History of Changes
Other Study ID Numbers: FCCC-02010
CDR0000069491 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G02-2095
First Submitted: July 8, 2002
First Posted: May 26, 2003
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
Neoplasms
Breast Diseases
Skin Diseases