Clinical trial · Interventional
HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix
Human Papillomavirus Detection and Genotyping by DR. HPV Genotyping IVD Kit in Exfoliated Cells of the Uterine Cervix
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| HPV Infection | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DR. Chip HPV genotyping IVD kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- study arm
- 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.
- interventionNames
- Device: DR. Chip HPV genotyping IVD kit
Primary outcomes (1)
- measure
- Agreement
- timeFrame
- within one week after sample collected by a study physician
- description
- agreement, sensitivity, and specificity compared to DNA sequencing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available