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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472377
• Other study ID #: HT19-HPV-01
• Status: Completed
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: April 18, 2022

Study information

• Verified date: April 2022
• Source: Hygeia Touch Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections
• Self Sampling
• Vaginal Discharge

Intervention

Device:
• Self sampling kit for collecting discharge from vaginal fornix
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Hygeia Touch Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

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