HPV Typing Between Self- and Physician-sampled (NCT04472377) | Clinical Trial Compass
CompletedNot Applicable
HPV Typing Between Self- and Physician-sampled
Taiwan1,210 participantsStarted 2020-05-29
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. with no history or current cervical intraepithelial lesion or malignancy.
✓. with a history of abnormal Pap test including atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell.
✓. with a history of atypical squamous cells favor high-grade squamous intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.
✓. with current atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell.
✓. with current abnormal Pap test as atypical squamous cells favor high-grade squamous intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.
Exclusion criteria
✕. History of total hysterectomy
✕. Pregnant
✕. Current cervicitis that requires therapy
✕. Received treatment for cervical lesion within 90 days
✕. Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina
What they're measuring
1
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.