Clinical trial · Interventional
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
- 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)
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Conditions
Conditions (7)
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 Screening | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cytology | — | UNRESOLVED | — |
| Diagnostic Accuracy | — | UNRESOLVED | — |
| High-risk Human Papillomavirus | — | UNRESOLVED | — |
| Histology | — | UNRESOLVED | — |
| p16 Protein | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| p16 protein expression | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.
- interventionNames
- Diagnostic Test: p16 protein expression
Primary outcomes (1)
- measure
- Diagnostic accuracy of p16 protein expression
- timeFrame
- Two years
- description
- Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older * Signed an approved informed consents * With sufficient cytology sample for p16 testing * With definite results of cytology and/or high-risk human papillomavirus and cervical histology Exclusion Criteria: * Not meeting all of the inclusion criteria
References
Publications (0)
Data not yet available