Clinical trial · Interventional
HPV Typing Between Self- and Physician-sampled
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
NCT04472377CI-TRIAL-00081301completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Self Sampling | — | UNRESOLVED | — |
| Vaginal Discharge | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self sampling kit for collecting discharge from vaginal fornix | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- study population
- description
- 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.
- interventionNames
- Device: Self sampling kit for collecting discharge from vaginal fornix
Primary outcomes (1)
- measure
- Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
- timeFrame
- 14 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTChou 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
- RESULTYang 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