Clinical trial · Observational
Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia
Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia
NCT04274465CI-TRIAL-00082525completedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.
Conditions
Conditions (2)
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 |
| Cervix Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| digital PCR (dPCR) assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Control
- description
- Negative high risk (HR)-HPV, cytology co-test
- interventionNames
- Diagnostic Test: digital PCR (dPCR) assay
- label
- CIN 1
- description
- Biopsy with low grade dysplasia
- interventionNames
- Diagnostic Test: digital PCR (dPCR) assay
- label
- CIN 2-3
- description
- Biopsy with high grade dysplasia
- interventionNames
- Diagnostic Test: digital PCR (dPCR) assay
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * No history of previously treated cervical cancer * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee Exclusion Criteria: * Women who are pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.