Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06042543
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-09-06
Brief Title:
Novel One Stop Affordable Point of Care and AI Supported System of Screening Triage and Treatment Selection for Cervical Cancer in LMICs
Sponsor:
Organization:
International Agency for Research on Cancer
Study Design
Study Type:
INTERVENTIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
The women participating in the study will be asked to provide two types of samples at recruitment
1 Urine sample Women will self-collect 10ml of first-stream Urine using the ColipeeTM collecting device in the clinic After HPV testing the leftover samples will be aliquoted and stored at -70C 2 Vaginal self-sampling Women will self-collect an upper vaginal sample using a dry swab In the lab the swab will be washed in 4ml of preservation medium After HPV testing the leftover samples will be aliquoted and stored at -70C Stored samples will be used for quality assurance and to address any discordant results between Urine and cervical cell sampling
Enrollment Count:
3200
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Other |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 99198 |
Who Masked List: