Comparison of Biomarkers Based on Fine-Needle Aspiration... | NCT00041353

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

NCT00041353

Sponsor

Fox Chase Cancer Center

Status

Withdrawn

Last Update Posted

Jul 11, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

cytology specimen collection procedure
comparison of screening methods
study of high risk factors

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CDR0000069491	Registry Identifier	PDQ (Physician Data Query)
NCI-G02-2095

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not activated at Fox Chase Cancer Center

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Sep 2002Actual

Completion Date

Sep 2002Actual

First Submitted Date

Jul 8, 2002

First Submission Date that Met QC Criteria

May 23, 2003

First Posted Date

May 26, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2013

Last Update Posted Date

Jul 11, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001943	Breast Neoplasms
D002285	Carcinoma, Intraductal, Noninfiltrating
D000071960	Breast Carcinoma In Situ

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Name	Type	Description	Arm Group Labels	Other Names
cytology specimen collection procedure	Other
comparison of screening methods	Procedure
study of high risk factors	Procedure