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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Human Papillomavirus Detection and Genotyping by DR. HPV Genotyping IVD Kit in Exfoliated Cells of the Uterine Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333212
• Other study ID #: MA1103L9
• Status: Completed
• Phase: N/A
• Start date: December 12, 2012
• Est. completion date: July 8, 2014

Study information

• Verified date: April 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1103
• Est. completion date: July 8, 2014
• Est. primary completion date: December 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Communicable Diseases
• HPV Infection
• Human Papillomavirus Infection
• Infection
• Papillomavirus Infections

Intervention

Device:
• DR. Chip HPV genotyping IVD kit
HPV typing by gene chip

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Cathay General Hospital	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Dr. Chip Biotechnology Incorporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement	agreement, sensitivity, and specificity compared to DNA sequencing	within one week after sample collected by a study physician