HPV Typing Between Self- and Physician-sampled

NCT04472377 | Completed Results DMC

• 1 other identifier: HT19-HPV-01
• Study Type: interventional
• Target: 1,210
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Papillomavirus Infection; Self Sampling; Vaginal Discharge

Keywords

cervical screening; human papillomavirus typing; self sampling

Outcome Measures

Primary Outcomes (1)

• Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected 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.

  14 days

Secondary Outcomes (3)

• Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample

  14 days

• Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens

  14 days

• Adverse Event From Self Sampling

  within one month after sample collection

Study Arms (1)

study population

EXPERIMENTAL

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.

Device: Self sampling kit for collecting discharge from vaginal fornix

Interventions

Self sampling kit for collecting discharge from vaginal fornix DEVICE

A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.

Also known as: Hygeia Touch Self Sampling Kit for Women

study population

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Detection of HPV in female genital tract.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hygeia Touch Inc.: lead

Study Sites (3)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833161, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 38420851 RESULT

• 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.

  PMID: 39036090 RESULT

MeSH Terms

Conditions

Papillomavirus Infections; Vaginal Discharge

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: Lance Yang
• Organization: Hygeia Touch Inc.

cyyang@hygeiatouch.com

+886-3-6675616

Study Officials

• Hung-Hsueh Chou, MBBS, VS

  Chang Gung Memorial Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the specimen was marked by code which was intended to mask the sample pairing
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: May 29, 2020
• Primary Completion: December 21, 2021
• Study Completion: April 18, 2022
• Last Updated: October 3, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 3 months after accepting for report publication
• Access Criteria: to the public

Locations

TW (3)