Clinical trial · Interventional
Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
- 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)
The objective of this study is to verify the clinical effectiveness of HPV Genotyping Nucleic Acid Assay Kit. This is a multi-center clinical study involving at least three study centers, each with screening sites. The protocol describes two study phases: Phase I is a baseline study of the screened population and ASCUS referral population (if necessary), the data of which will be submitted after the baseline study is completed; Phase II is a three-year follow-up study of the screened population, the data of which will be submitted again after the follow-up is completed.
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV Genotyping Nucleic Acid Assay Kit | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening population and ASCUS referral population
- description
- The screening population: Two cervical cytology samples will be collected from each subject. The 1st tube of SurePath liquid-based cytology sample is used for cytology test and BD Onclarity Assay HPV detection. Subjects with cytology test results ≥ ASCUS or positive HPV test results will be suggested to return for baseline colposcopy within approximately 12 weeks. In case of visible lesions under colposcopy, a biopsy of tissues at the site of the lesion will be performed; in case of no visible lesions, randombiopsy and/or ECC will be performed. Patients with histopathological results ≥ CIN2 will completed the study. ASCUS referral population: Female subjects with an ASCUS cytology result will be recalled undergo colposcopy, the remaining samples for cytology test collected prior to enrollment will be used for BD Onclarity Assay HPV test.
- interventionNames
- Diagnostic Test: HPV Genotyping Nucleic Acid Assay Kit
Primary outcomes (4)
- measure
- Verification of the accuracy of nucleic acid assay
- timeFrame
- 12 weeks
- description
- The results of HPV Assay of test product and reference product
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects ≥ 21 of age and \< 65 of age * Subjects who have signed the inform consent form Exclusion Criteria: * Pregnant subjects * Subjects who have had cervical cytology samples taken in the last 12 months * Subjects who have previously undergone a total hysterectomy * Subjects who have previously undergone cone resection, LEEP, cervical laser surgery, cervical cryosurgery or uterine ablation within 3 years * Subjects who are participating in other clinical trials of cervical disease diagnostic products
References
Publications (0)
Data not yet available