Human Papillomavirus Infection, Self Sampling, Vaginal Discharge
Conditions
Keywords
cervical screening, human papillomavirus typing, self sampling
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
Interventions
DEVICESelf sampling kit for collecting discharge from vaginal fornix
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
Sponsors
Hygeia Touch Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
the specimen was marked by code which was intended to mask the sample pairing
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | 14 days | 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. |
| Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | 14 days | Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens. |
| Adverse Event From Self Sampling | within one month after sample collection | The number of participants with any adverse event. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Population 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.
Self sampling kit for collecting discharge from vaginal fornix: A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort. | 1,210 |
| Total | 1,210 |
Baseline characteristics
| Characteristic | Study Population | — |
|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 10.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1210 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,210 |
| other Total, other adverse events | 9 / 1,210 |
| serious Total, serious adverse events | 0 / 1,210 |
Outcome results
Primary
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.
Time frame: 14 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-collected Specimens | Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Positive | 581 Participants |
| Self-collected Specimens | Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Negative | 589 Participants |
| Physician-sampled Specimens | Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Positive | 611 Participants |
| Physician-sampled Specimens | Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Negative | 559 Participants |
Secondary
Adverse Event From Self Sampling
The number of participants with any adverse event.
Time frame: within one month after sample collection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-collected Specimens | Adverse Event From Self Sampling | 9 Participants |
Secondary
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.
Time frame: 14 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-collected Specimens | Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Positive | 718 Participants |
| Self-collected Specimens | Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Negative | 452 Participants |
| Physician-sampled Specimens | Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Positive | 720 Participants |
| Physician-sampled Specimens | Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Negative | 450 Participants |
Secondary
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.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-collected Specimens | Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | 1170 Participants |
| Physician-sampled Specimens | Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | 1170 Participants |