Human Papillomavirus Infection Clinical Trial
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
NCT number | NCT04472377 |
Other study ID # | HT19-HPV-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 29, 2020 |
Est. completion date | April 18, 2022 |
Verified date | April 2022 |
Source | Hygeia Touch Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1210 |
Est. completion date | April 18, 2022 |
Est. primary completion date | December 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: 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, 1. with no history or current cervical intraepithelial lesion or malignancy. 2. with a history of abnormal Pap test including atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell. 3. 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. 4. with current atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell. 5. 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: 1. History of total hysterectomy 2. Pregnant 3. Current cervicitis that requires therapy 4. Received treatment for cervical lesion within 90 days 5. Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina 6. Had sexual activity without a condom in 48 hours 7. Excessive vaginal discharge, either in the ovulation period or due to inflammation 8. is undergoing local therapy with an intravaginal tablet or residual drug in the vaginal canal 9. during mense |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | Linkou Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Hygeia Touch Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement in the detection of high-risk HPV type in physician collected specimen and patient sampled specimen. | Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen. | through study completion, an average of 1 year | |
Secondary | Agreement in HPV detection between physician collected sample and self-collected sample | Rate of the "agreement". The "agreement" is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen. | through study completion, an average of 1 year | |
Secondary | Percentage of a valid specimen, according to the presence of the beta-globin gene in the self-collected specimen, and compares to the physician-collected specimen | Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens. | through study completion, an average of 1 year | |
Secondary | Any adverse event resulted from collecting the specimen | The number of participants with any adverse event. | within one month after sample collection |
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