At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Participation in Screening for Cervical Cancer: Interest of a Human Papillomavirus (HPV) Self-sampling Device Provided by the General Practitioner; a Cluster Randomized Clinical Trial
In Brief
A clinical study evaluating Vaginal self-sampling brush for Malignant Tumor of Cervix and Cervical Intraepithelial Neoplasia. Completed, enrolled 308 participants across 1 site.
Detailed Summary
This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.
Study Details
Timeline
Interventions
Self-collection by unscreened women aged from 30 to 65 of a vaginal sample with the device. After collection, the whole device is mailed in a normalized for biological samples package to the virology lab of the University Hospital of Lille where a HPV test is conducted using a Cobas 4800 technique.