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

NCT04333212 | Completed

• 1 other identifier: MA1103L9
• Study Type: interventional
• Target: 1,103
• Locations: 1 country
• Sites: 4

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 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

Outcome Measures

Primary Outcomes (1)

• Agreement

  agreement, sensitivity, and specificity compared to DNA sequencing

  within one week after sample collected by a study physician

Study Arms (1)

study arm

OTHER

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.

Device: DR. Chip HPV genotyping IVD kit

Interventions

DR. Chip HPV genotyping IVD kit DEVICE

HPV typing by gene chip

study arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: HPV detection and typing for exfoliated cervical cells
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y/o female with sexual exposure
• Written informed consent
• Either one of the following conditions:
• a. 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Dr. Chip Biotechnology Incorporation: collaborator

Study Sites (4)

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairperson

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: December 12, 2012
• Primary Completion: December 30, 2013
• Study Completion: July 8, 2014
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months after accepting for report publication
• Access Criteria: to the public

Locations

TW (4)