Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039312
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2002-06-06
Brief Title:
Comparison of Screening Tests in Detecting Cervical Neoplasia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Multi-Institutional Prospective Cohort Study For The Comparison Of Different Primary Screening Strategies For The Detection Of Cervical Neoplasia
Status:
COMPLETED
Status Verified Date:
2012-07
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 Screening tests may help doctors detect abnormal cells in the cervix early and plan effective treatment
PURPOSE Screening trial to compare different types of screening tests used to detect cervical neoplasia
PURPOSE Screening trial to compare different types of screening tests used to detect cervical neoplasia
Detailed Description:
OBJECTIVES
Compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia
Compare the positive and negative predictive values of these strategies
OUTLINE This is a multicenter study Patients are stratified according to the reason for the visit general gynecological screening vs colposcopy referral
Stratum 1 general gynecological screening Patients undergo Pap smear visual inspection aided by acetic acid VIA a colposcopy and finally a visual inspection aided by toluidine blue VIT followed by an acetic acid wash A biopsy may be performed at this initial visit Within 2-3 weeks patients are notified of results
Stratum 2 colposcopy referral Patients undergo Pap smear VIA colposcopy VIT and possible biopsy as in stratum 1 During the same visit patients receive histologic evaluation and treatment with See-and-Treat loop electrosurgical excision procedure andor endocervical curettage
PROJECTED ACCRUAL A total of 600-1000 patients 300-500 per stratum will be accrued for this study
Compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia
Compare the positive and negative predictive values of these strategies
OUTLINE This is a multicenter study Patients are stratified according to the reason for the visit general gynecological screening vs colposcopy referral
Stratum 1 general gynecological screening Patients undergo Pap smear visual inspection aided by acetic acid VIA a colposcopy and finally a visual inspection aided by toluidine blue VIT followed by an acetic acid wash A biopsy may be performed at this initial visit Within 2-3 weeks patients are notified of results
Stratum 2 colposcopy referral Patients undergo Pap smear VIA colposcopy VIT and possible biopsy as in stratum 1 During the same visit patients receive histologic evaluation and treatment with See-and-Treat loop electrosurgical excision procedure andor endocervical curettage
PROJECTED ACCRUAL A total of 600-1000 patients 300-500 per stratum will be accrued for this study
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-G02-2076 | None | None | None |
| UCLA-9910034 | None | None | None |