Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041353
Status:
WITHDRAWN
Last Update Posted:
2013-07-11
First Post:
2002-07-08
Brief Title:
Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Breast Cancer Biomarkers Based on Fine Needle Aspirates
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not activated at Fox Chase Cancer Center
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069491 | REGISTRY | None | None |
| NCI-G02-2095 | Registry Identifier | PDQ Physician Data Query | None |