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

NCT04333212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1103

Last updated 2020-04-03

No results posted yet for this study

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.

Conditions

  • Cervical Intraepithelial Neoplasia
  • Human Papillomavirus Infection
  • HPV Infection

Interventions

DEVICE

DR. Chip HPV genotyping IVD kit

HPV typing by gene chip

Sponsors & Collaborators

  • Dr. Chip Biotechnology Incorporation

    collaborator OTHER

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2013-12-30
Completion
2014-07-08

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333212 on ClinicalTrials.gov