Status:
COMPLETED
HPV Typing Between Self- and Physician-sampled
Lead Sponsor:
Hygeia Touch Inc.
Conditions:
Human Papillomavirus Infection
Self Sampling
Eligibility:
FEMALE
21-65 years
Phase:
NA
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 Papillomavir...
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. Agreem...
Eligibility Criteria
Inclusion
- 1\. Woman with a uterine cervix, i.e., with no previous total hysterectomy or radiotherapy for cervical tumor. The woman who received subtotal hysterectomy is allowed.
- 2\. Signed informed consent. 3. Fit any one of the following conditions,
- 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
- 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
- Had sexual activity without a condom in 48 hours
- Excessive vaginal discharge, either in the ovulation period or due to inflammation
- is undergoing local therapy with an intravaginal tablet or residual drug in the vaginal canal
- during mense
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2022
Estimated Enrollment :
1210 Patients enrolled
Trial Details
Trial ID
NCT04472377
Start Date
May 29 2020
End Date
April 18 2022
Last Update
October 3 2024
Active Locations (3)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833161
2
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
3
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 33305