Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004091
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
1999-12-10
Brief Title:
Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 abnormal cervical cells may improve the ability to detect these cells and plan effective treatment
PURPOSE Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results
PURPOSE Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results
Detailed Description:
OBJECTIVES I Compare the detection of transferrin receptor epidermal growth factor receptor and the MaTu-MN protein in exfoliated cervical epithelial cells from women with abnormal Pap test using fluorescent labeled antibody probe vs histology
OUTLINE Patients undergo a Pap test and a colposcopy Cervical epithelial cells are collected from the most abnormal appearing lesion Cells are examined for molecular markers using a fluorescent antibody test The presence or absence of these markers is compared to results of the Pap test and the histology of the cells
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 6 months
OUTLINE Patients undergo a Pap test and a colposcopy Cervical epithelial cells are collected from the most abnormal appearing lesion Cells are examined for molecular markers using a fluorescent antibody test The presence or absence of these markers is compared to results of the Pap test and the histology of the cells
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 6 months
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 |
|---|---|---|---|
| NCI-G99-1582 | None | None | None |
| NU-99G3 | None | None | None |