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

Chang Gung Medical Foundation

Status: Completed

Conditions: HPV Infection; Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia

Treatments: Device: DR. Chip HPV genotyping IVD kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04333212

MA1103L9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,103 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,103 participants in 1 patient group

study arm

Other group

Description:

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.

Treatment:

Device: DR. Chip HPV genotyping IVD kit