Clinical trial · Observational
HPV Integration Testing for Cervical Cancer Screening
HPV（Human Papillomavirus） Integration Testing for Cervical Cancer Screening
NCT02576158CI-TRIAL-00028283unknownClinicalTrials.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 primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.
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 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TCT，HPV，colposcopic inspection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects will be women, 30-65 years of age
- description
- Patients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment.
- interventionNames
- Procedure: TCT，HPV，colposcopic inspection
Primary outcomes (1)
- measure
- the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT
- timeFrame
- 14 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Women aged 30-65 years old Attending the China population-based organised cervical screening program Exclusion Criteria: 1. Not providing informed consent 2. previously confirmed CIN, cervical cancer, or other malignancies 3. previous therapeutic procedure to cervix 4. pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.