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

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HPV Infection Human Papillomavirus Infection Infections Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital, Changhua, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR. Chip HPV genotyping IVD kit

Device

HPV typing by gene chip

Primary outcomes

Agreement

Time frame: within one week after sample collected by a study physician

agreement, sensitivity, and specificity compared to DNA sequencing

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

Dr. Chip Biotechnology Incorporation

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Apr 3, 2020
Registry last updated: Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed