HPV Typing Between Self- and Physician-sampled

Not Applicable

Completed

• Conditions: Human Papillomavirus Infection; Self Sampling; Vaginal Discharge
• Interventions: Device: Self sampling kit for collecting discharge from vaginal fornix

• Registration Number: NCT04472377
• Lead Sponsor: Hygeia Touch Inc.

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

Study Timeline

• Study Start: 2020-05-29
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-15
• Primary Completion: 2021-12-21
• Study Completion: 2022-04-18
• Results First Submitted: 2023-07-21
• Results First Submitted QC: 2024-03-07
• Results First Posted: 2024-08-12
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-19
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1210

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,

3. with no history or current cervical intraepithelial lesion or malignancy.

4. with a history of abnormal Pap test including atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell.

5. 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.

6. with current atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell.

7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study population	Self sampling kit for collecting discharge from vaginal fornix	We enroll a total of 1,200 women, as follows, 1. 120 cases with no history or current cervical intraepithelial lesion or malignancy. 2. 180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell. 3. 240 cases with a history of atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. 4. 240 cases with current ASCUS, CIN1, or atypical glandular cell. 5. 420 cases with current abnormal Pap test as atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.

Primary Outcome Measures

Name	Time	Method
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.	14 days	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.

Secondary Outcome Measures

Name	Time	Method
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample	14 days	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.
Adverse Event From Self Sampling	within one month after sample collection	The number of participants with any adverse event.
Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens	14 days	Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.

Trial Locations

Locations (3)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan