Clinical trial NCT04472377: HPV Typing Between Self- and Physician-sampled
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Self Sampling
Vaginal Discharge
Keywords: cervical screening
human papillomavirus typing
self sampling
Lead sponsor: Hygeia Touch Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 1210
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two samples were collected, one by the study investigator using a cervical swab and another one by the patient using the study device immediately after viewing the instruction video and illustration. The association of the self-collected sample and the physician-collected sample was blinded to the laboratory personnel.
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
timeFrame: 14 days
Secondary outcomes:
measure: Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample
timeFrame: 14 days
measure: Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens
timeFrame: 14 days
measure: Adverse Event From Self Sampling
timeFrame: within one month after sample collection
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hung-Hsueh Chou, MBBS, VS
role: STUDY_CHAIR
References:
citation: Chou HH, Yang CY, Chao A, Lin H, Lu CH, Ou YC, Hsu ST, Shih YH, Huang HJ, Lin CT, Chen MY, Sun L, Tsai CC, Fu HC, Huang KG, Wu KY, Wu CH, Hsieh WC, Huang YT, Chen LH, Yang LY, Chang WY, Chang TC, Lai CH. Consistency in human papillomavirus type detection between self-collected vaginal specimens and physician-sampled cervical specimens. J Med Virol. 2024 Mar;96(3):e29426. doi: 10.1002/jmv.29426.
citation: Yang CY, Chang TC, Chou HH, Chao A, Hsu ST, Shih YH, Huang HJ, Lin CT, Chen MY, Sun L, Huang KG, Wu KY, Hsieh WC, Huang YT, Chen LH, Lu CH, Lin H, Cheng CM. Evaluation of a novel vaginal cells self-sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability. Bioeng Transl Med. 2024 Mar 13;9(4):e10653. doi: 10.1002/btm2.10653. eCollection 2024 Jul.