Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479375
Status:
COMPLETED
Last Update Posted:
2007-05-28
First Post:
2007-05-25
Brief Title:
Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening
Status:
COMPLETED
Status Verified Date:
2007-05
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:
SWEDESCREEN
Brief Summary:
Human papillomavirus HPV-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia CIN Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect
Methods A total of 12527 women aged 32-38 attending population-based invitational screening in Sweden were randomized 11 to HPV test and cytology intervention arm or cytology only control arm HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy A similar number of random double-blinded procedures are performed in the control arm Women are followed with comprehensive registry-based follow-up Primary outcome is the relative rates of CIN grade 2 or worse CIN2CIN3 found in subsequent screening Secondary outcomes are the relative rates of CIN2CIN3 found in the aseline screening and outcomes stratified by grade of CIN CIN 2 or CIN3
Methods A total of 12527 women aged 32-38 attending population-based invitational screening in Sweden were randomized 11 to HPV test and cytology intervention arm or cytology only control arm HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy A similar number of random double-blinded procedures are performed in the control arm Women are followed with comprehensive registry-based follow-up Primary outcome is the relative rates of CIN grade 2 or worse CIN2CIN3 found in subsequent screening Secondary outcomes are the relative rates of CIN2CIN3 found in the aseline screening and outcomes stratified by grade of CIN CIN 2 or CIN3
Detailed Description:
None
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