search
Back to results

HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix

Primary Purpose

Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection, HPV Infection

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
DR. Chip HPV genotyping IVD kit
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 21-65 y/o female with sexual exposure
  2. Written informed consent
  3. Either one of the following conditions:

3a. No previous history of abnormal cervical cytology or abnormal histology for women enrolled in no intraepithelial lesion or malignancy (NILM) group 3b. Abnormal cervical cytology other than atrophic change, reactive change or glandular cells favored of the endometrial origin

Exclusion Criteria:

  1. Current pregnancy
  2. Previous total hysterectomy
  3. Cervicovaginal infection required treatment
  4. Received cervical ablative therapy within 1 year

Sites / Locations

  • Changhua Christian Hospital
  • Mackay Memorial Hospital
  • Cathay General Hospital
  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

study arm

Arm Description

We projected a total of 1,100 study cases, which encompassed 100 cases of women with no intraepithelial lesion or malignancy (NILM) cytology, 300 cases of ASCUS, 300 cases of low grade squamous intraepithelial lesion (LSIL) and 400 cases high grade squamous intraepithelial lesion (HSIL) in cervical cytology.

Outcomes

Primary Outcome Measures

Agreement
agreement, sensitivity, and specificity compared to DNA sequencing

Secondary Outcome Measures

Full Information

First Posted
April 1, 2020
Last Updated
April 1, 2020
Sponsor
Chang Gung Memorial Hospital
Collaborators
Dr. Chip Biotechnology Incorporation
search

1. Study Identification

Unique Protocol Identification Number
NCT04333212
Brief Title
HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix
Official Title
Human Papillomavirus Detection and Genotyping by DR. HPV Genotyping IVD Kit in Exfoliated Cells of the Uterine Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2012 (Actual)
Primary Completion Date
December 30, 2013 (Actual)
Study Completion Date
July 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Dr. Chip Biotechnology Incorporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.
Detailed Description
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. HPV detection is also applied for triage of atypical squamous cells of undetermined significance and follow-up after treatment for cervical neoplasms. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard. One-thousand one-hundred and three (1103) subjects were enrolled between December 2012 and December 2013 from Linkou Chang Gung Memorial Hospital, Mackay Memorial Hospital, Changhua Christian Hospital, and Cathay General Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection, HPV Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Other
Arm Description
We projected a total of 1,100 study cases, which encompassed 100 cases of women with no intraepithelial lesion or malignancy (NILM) cytology, 300 cases of ASCUS, 300 cases of low grade squamous intraepithelial lesion (LSIL) and 400 cases high grade squamous intraepithelial lesion (HSIL) in cervical cytology.
Intervention Type
Device
Intervention Name(s)
DR. Chip HPV genotyping IVD kit
Intervention Description
HPV typing by gene chip
Primary Outcome Measure Information:
Title
Agreement
Description
agreement, sensitivity, and specificity compared to DNA sequencing
Time Frame
within one week after sample collected by a study physician

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
HPV detection and typing for exfoliated cervical cells
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21-65 y/o female with sexual exposure Written informed consent Either one of the following conditions: 3a. No previous history of abnormal cervical cytology or abnormal histology for women enrolled in no intraepithelial lesion or malignancy (NILM) group 3b. Abnormal cervical cytology other than atrophic change, reactive change or glandular cells favored of the endometrial origin Exclusion Criteria: Current pregnancy Previous total hysterectomy Cervicovaginal infection required treatment Received cervical ablative therapy within 1 year
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
106
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

Learn more about this trial

HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix

We'll reach out to this number within 24 hrs