N/A
N=1,210
HPV Typing Between Self- and Physician-sampled
Human Papillomavirus Infection · Self Sampling · Vaginal Discharge
Bottom Line
View on ClinicalTrials.gov: NCT04472377 ↗Enrolled (actual)
1,210
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. — 581; 611; 589; 559 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self sampling kit for collecting discharge from vaginal fornix (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Hygeia Touch Inc.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. |
581; 611; 589; 559 | — |
| SECONDARY Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample |
718; 720; 452; 450 | — |
| SECONDARY Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens |
1170; 1170 | — |
| SECONDARY Adverse Event From Self Sampling |
9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04472377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.