Human Papillomavirus InfectionNCT04472377
HPV Typing Between Self- and Physician-sampled
A study testing Self sampling kit for collecting discharge from vaginal fornix in people with Human Papillomavirus Infection and Self Sampling, run by Hygeia Touch Inc. at 3 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection, Self Sampling, Vaginal Discharge
- What is being tested?
- Self sampling kit for collecting discharge from vaginal fornix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,210 participants
- Where
- 3 sitesTaiwan
- Study dates
- 29 May 2020to 18 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833161
Taichung Veterans General Hospital
Taichung, 40705
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
About this study
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
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.
Read the detailed description
Primary end-point:
- 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
- Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample
Secondary end-point:
- Percentage of the valid sample between self-collected and physician-collected specimens
- Agreement of all (N = 27) HPV types between the paired samples
- Adverse events associated with sample collection
- 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
- Correlation between histological diagnosis and HPV types
- Being tested
- Self sampling kit for collecting discharge from vaginal fornix
- Keywords
- cervical screening, human papillomavirus typing, self sampling
- Medical subject headings
- Papillomavirus Infections, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self sampling kit for collecting discharge from vaginal fornixDevice
Also called Hygeia Touch Self Sampling Kit for Women
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Self sampling kit for collecting discharge from vaginal fornix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (3)
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample
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.
Measured: 14 days
Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens
Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
Measured: 14 days
Adverse Event From Self Sampling
The number of participants with any adverse event.
Measured: within one month after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start29 May 2020
- Primary completion21 Dec 2021
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 1,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hygeia Touch Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hung-Hsueh Chou, MBBS, VS, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472377
- Sponsor's protocol ID
- HT19-HPV-01
- Status last verified
- Sep 2024
- First submitted
- 9 Jul 2020
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For clinical trial participation.
Publications
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.
PubMed 38420851Yang 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.
PubMed 39036090Yang CY, Chang TC, Lee YT, Shih TY, Li CW, Cheng CM. Exploring the Interplay Between Cervicovaginal Microbiome, HPV Infection, and Cervical Intraepithelial Neoplasia in Taiwanese Women. J Med Virol. 2025 Feb;97(2):e70190. doi: 10.1002/jmv.70190.
PubMed 39868896
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04472377
- Acronym / sponsor ID
- HT19-HPV-01
- Keywords
- cervical screening, human papillomavirus typing, self sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,210 participants (actual)
- Lead sponsor
- Hygeia Touch Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample
Secondary end-point:
- Percentage of the valid sample between self-collected and physician-collected specimens
- Agreement of all (N = 27) HPV types between the paired samples
- Adverse events associated with sample collection
- 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
- Correlation between histological diagnosis and HPV types
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| study population | Experimental | Device: Self sampling kit for collecting discharge from vaginal fornixWe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self sampling kit for collecting discharge from vaginal fornixAlso: Hygeia Touch Self Sampling Kit for WomenA device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort. | Device | study population |
Primary outcome
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
Time frame: 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.
3 secondary outcomes
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample
Time frame: 14 days
Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens
Time frame: 14 days
Adverse Event From Self Sampling
Time frame: within one month after sample collection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38420851Chou 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.
- Results publication: PubMed 39036090Yang 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.
- Derived from this study: PubMed 39868896Yang CY, Chang TC, Lee YT, Shih TY, Li CW, Cheng CM. Exploring the Interplay Between Cervicovaginal Microbiome, HPV Infection, and Cervical Intraepithelial Neoplasia in Taiwanese Women. J Med Virol. 2025 Feb;97(2):e70190. doi: 10.1002/jmv.70190.
- Individual participant dataSharing planned: Yes. For clinical trial participation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Hsueh Chou, MBBS, VS study chair
Chang Gung Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self sampling kit for collecting discharge from vaginal fornix in people with Human Papillomavirus Infection and Self Sampling, run by Hygeia Touch Inc. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04472377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.