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

Not Applicable

Completed

• Conditions: Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia; HPV Infection
• Interventions: Device: DR. Chip HPV genotyping IVD kit

• Registration Number: NCT04333212
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2012-12-12
• Primary Completion: 2013-12-30
• Study Completion: 2014-07-08
• Status Verified: 2020-04
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study arm	DR. Chip HPV genotyping IVD kit	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.

Primary Outcome Measures

Name	Time	Method
Agreement	within one week after sample collected by a study physician	agreement, sensitivity, and specificity compared to DNA sequencing

Trial Locations

Locations (4)

Cathay General Hospital; 🇨🇳 Taipei, Taiwan

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan