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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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