Clinical trial · Observational
Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women
Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women：a Prospective Cohort Study
- 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 American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.
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 |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV integration test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Risk of CIN2+ disease
- timeFrame
- 3 years
- description
- CIN2+ diagnosed on biopsy obtained at colposcopy.
- measure
- Risk of CIN3+ disease
- timeFrame
- 3 years
- description
- CIN3+ diagnosed on biopsy obtained at colposcopy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Consenting women aged 20y-70y with HPV-positive results Exclusion Criteria: * Not providing informed consent * previously confirmed CIN, cervical cancer, or other malignancies * previous therapeutic procedure to cervix * pregnancy
References
Publications (0)
Data not yet available