Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03931083
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2019-04-15
Brief Title:
Screening Test Accuracy of Gynocular HR-HPV Testing VIA for Detection of Cervical Neoplastic Lesions in Women Living With HIV
Sponsor:
Organization:
University of Bern
Study Design
Study Type:
OBSERVATIONAL
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:
For a biopsy a very small sample appr 2X2X1 mm3 of tissue is taken from the cervix The study nurse will take the biopsies after the Gynocular exam Biopsies are taken of all acetowhite lesions If no lesions are seen a total of 4 biopsies will be taken within the transformation zone 12 3 6 and 9 o clock positions Bleeding is minimal the biopsy site does not require stitches The length of time it takes for this to heal varies but can be approximately 7 days If the study participant informs the study nurse of any biopsy-related adverse event AE the study nurse will record this information in the study-specific data collection tool for AEs The clinical team will manage the AE according to national guidelines and follow-up with the participant until the event is resolved
Enrollment Count:
450
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Other |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 55824 |
Who Masked List: