Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03856684
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2019-02-26
Brief Title:
Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Randomized Trial Evaluating Womens Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit
Status:
COMPLETED
Status Verified Date:
2021-10
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:
APACHE-4
Brief Summary:
Despite the existence of an effective screening test pap smear cervical cancer is every year in France the cause of more than 3000 new cases and 1100 deaths But in France 4 in 10 women are not screened or not often enough nearly 7 millions women It is therefore necessary to develop new strategies to reach these women The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus HR-HPV Thereby HPV-based tests could be alternative screening tests Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear It has been shown that sending vaginal self-sampling kit with HPV test to unscreened womens home is a powerful means to increase the participation rate of cervical cancer screening It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent Two approaches will be tested a system available on request of the kit and or the addition of an SMS Short Message Service reminder
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None