Status:

COMPLETED

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

Lead Sponsor:

Chang Gung Memorial Hospital

Collaborating Sponsors:

Dr. Chip Biotechnology Incorporation

Conditions:

Cervical Intraepithelial Neoplasia

Human Papillomavirus Infection

Eligibility:

FEMALE

21-65 years

Phase:

NA

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 pr...

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 pr...

Eligibility Criteria

Inclusion

  • 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

  • Current pregnancy
  • Previous total hysterectomy
  • Cervicovaginal infection required treatment
  • Received cervical ablative therapy within 1 year

Key Trial Info

Start Date :

December 12 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 8 2014

Estimated Enrollment :

1103 Patients enrolled

Trial Details

Trial ID

NCT04333212

Start Date

December 12 2012

End Date

July 8 2014

Last Update

April 3 2020

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Changhua Christian Hospital

Changhua, Taiwan, 50006

2

Mackay Memorial Hospital

Taipei, Taiwan, 104

3

Cathay General Hospital

Taipei, Taiwan, 106

4

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 33305