Spots Global Cancer Trial Database for Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface

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Trial Identification

Brief Title: Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface

Official Title: Evaluate the Agreement of High-risk Human Papillomavirus Type Between Self-collected Vaginal Discharge Sample Using "HygeiaTouch Self Sampling Kit for Woman" and Physician Collected Sample From the Cervix

Study ID: NCT04472377

Conditions

Human Papillomavirus Infection

Self Sampling

Vaginal Discharge

Interventions

Self sampling kit for collecting discharge from vaginal fornix

Study Description

Brief Summary: Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human Papillomavirus (hrHPV) detection. This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and these results will be applied for TFDA registration approval.

Detailed Description: Primary end-point: 1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, between the physician-collected sample and self-collected sample 2. Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample Secondary end-point: 1. Percentage of the valid sample between self-collected and physician-collected specimens 2. Agreement of all (N = 27) HPV types between the paired samples 3. Adverse events associated with sample collection 4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie and a brief illustration 5. Correlation between histological diagnosis and HPV types