Clinical trial · Observational
TS Triage of HR-HPV Positive Population and Its Accuracy Study
A Study on the Application of TS for Triage in HR-HPV Viral Load Positive Population and Accuracy Related Studies
NCT07777094CI-TRIAL-00122963active not recruitingClinicalTrials.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)
A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.
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 Precancerous Lesions | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colposcopy and cervical biopsy | Diagnostic Test | — | UNRESOLVED |
| Follow-up of TS false-positive patients | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- HPV16/18 - Low VL
- description
- HPV type 16/18 positive, low viral load group (1.00-99.99 RLU/PC)
- interventionNames
- Diagnostic Test: Colposcopy and cervical biopsy
- Diagnostic Test: Follow-up of TS false-positive patients
- label
- HPV16/18 - Medium VL
- description
- HPV type 16/18 positive, medium viral load group (100-999.99 RLU/PC)
- interventionNames
- Diagnostic Test: Colposcopy and cervical biopsy
- Diagnostic Test: Follow-up of TS false-positive patients
- label
- HPV16/18 - High VL
- description
- HPV type 16/18 positive, high viral load group (≥1000.00 RLU/PC)
- interventionNames
- Diagnostic Test: Colposcopy and cervical biopsy
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients in our outpatient clinic who have already undergone HPV viral load testing and are awaiting colposcopy, or those who have both HPV viral load test results and TS (Triple Staining) results and are awaiting colposcopy； 2. Informed consent obtained from voluntary participants. Exclusion Criteria: 1. Patients who are unable to cooperate or have poor compliance; 2. Within four months postpartum; 3. During the first three days of menstruation with heavy flow; 4. Within three months after cervical surgery (including cervical biopsy); 5. Previous radiotherapy in the pelvic region; 6. Currently undergoing chemotherapy or within five weeks after chemotherapy; 7. Clinically evident acute or subacute cervical/vaginal infection; 8. History of photosensitivity disorders, current photodynamic therapy, or exposure to photosensitizing agents; 9. Suspected or confirmed history of alcohol/drug abuse, or any other condition that-in the investigator's judgment-may reduce enrollment feasibility or complicate participation (e.g., frequent job relocation, unstable living conditions leading to high risk of loss to follow-up); 10. Other patients deemed ineligible by the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.