Back to resultsAgreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface
Primary Purpose
Human Papillomavirus Infection, Self Sampling, Vaginal Discharge
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self sampling kit for collecting discharge from vaginal fornix
Sponsored by
About this trial
This is an interventional diagnostic trial for Human Papillomavirus Infection focused on measuring cervical screening, human papillomavirus typing, self sampling
Eligibility Criteria
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,
- 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
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
- Taichung Veterans General Hospital
- Linkou Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study population
Arm Description
We enroll a total of 1,200 women, as follows, 120 cases with no history or current cervical intraepithelial lesion or malignancy. 180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell. 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. 240 cases with current ASCUS, CIN1, or atypical glandular cell. 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.
Outcomes
Primary Outcome Measures
Agreement in the detection of high-risk HPV type in physician collected specimen and patient sampled 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.
Secondary Outcome Measures
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.
Percentage of a valid specimen, according to the presence of the beta-globin gene in the self-collected specimen, and compares to the physician-collected specimen
Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
Any adverse event resulted from collecting the specimen
The number of participants with any adverse event.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04472377
Brief Title
Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
April 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hygeia Touch Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection, Self Sampling, Vaginal Discharge
Keywords
cervical screening, human papillomavirus typing, self sampling
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
the specimen was marked by code which was intended to mask the sample pairing
Allocation
N/A
Enrollment
1210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study population
Arm Type
Experimental
Arm Description
We enroll a total of 1,200 women, as follows,
120 cases with no history or current cervical intraepithelial lesion or malignancy.
180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell.
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.
240 cases with current ASCUS, CIN1, or atypical glandular cell.
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.
Intervention Type
Device
Intervention Name(s)
Self sampling kit for collecting discharge from vaginal fornix
Other Intervention Name(s)
Hygeia Touch Self Sampling Kit for Women
Intervention Description
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
Primary Outcome Measure Information:
Title
Agreement in the detection of high-risk HPV type in physician collected specimen and patient sampled specimen.
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Agreement in HPV detection between physician collected sample and self-collected sample
Description
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
through study completion, an average of 1 year
Title
Percentage of a valid specimen, according to the presence of the beta-globin gene in the self-collected specimen, and compares to the physician-collected specimen
Description
Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
Time Frame
through study completion, an average of 1 year
Title
Any adverse event resulted from collecting the specimen
Description
The number of participants with any adverse event.
Time Frame
within one month after sample collection
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Detection of HPV in female genital tract.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Hsueh Chou, MBBS, VS
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833161
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
For clinical trial participation.
IPD Sharing Time Frame
3 months after accepting for report publication
IPD Sharing Access Criteria
to the public
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Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface
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