Clinical Trials in China / NCT07777094
Active, not recruiting
Observational
TS Triage of HR-HPV Positive Population and Its Accuracy Study
NCT07777094 · tracked via the Priya Life Science China tracker
Condition(s) studied
Cervical Precancerous LesionsCervical Cancer
Investigational drug(s) / intervention(s)
Colposcopy and cervical biopsyFollow-up of TS false-positive patients
Colposcopy and cervical biopsy: The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Follow-up of TS false-positive patients: False-positive people with initial TS screening were followed up for 1 year, with a second TS examination six months after the initial TS screening.
Study summary
A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.
Eligibility
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.
Primary outcome measure(s)
- Sensitivity of TS for diagnosing populations with different HR-HPV subtypes and viral loads — January 2025 to December 2025
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-positive cases among pathologically confirmed patients was calculated for each subgroup to determine the differences in diagnostic sensitivity when using TS as a screening tool. - The specificity of TS in diagnosing individuals with different HR-HPV subtypes and viral loads — January 2025 to December 2025
Using the pathological diagnosis of cervical biopsy as the gold standard, the study subjects were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-negative cases among pathologically negative (non-lesional) patients was calculated for each subgroup to clarify the differences in clinical efficacy of the test as a triage tool in excluding non-lesional individuals and reducing unnecessary referral rates. - The positive predictive value of TS in populations with different HR-HPV subtypes and viral loads — January 2025 to December 2025
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-positive subjects in each subgroup who were pathologically confirmed to have lesions was calculated to assess the predictive ability of TS-positive results for cervical high-grade lesions and their clinical diagnostic value across different viral load levels. - Negative predictive value of TS in populations with different HR-HPV subtypes and viral loads — January 2025 to December 2025
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of subjects with a normal/non-lesional pathological diagnosis among those with a negative TS test result was calculated for each subgroup to assess the reliability of TS-negative results in ruling out cervical lesions and to determine the safety of using TS as a triage tool at different viral load levels. - The AUC of TS in diagnosing individuals with different HR-HPV subtypes and viral loads — January 2025 to December 2025
Using the pathological diagnosis of cervical biopsy as the gold standard, the study subjects were stratified into 6 detailed subgroups based on HR-HPV genotyping (HPV types 16/18 and other 12 types) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. By plotting receiver operating characteristic (ROC) curves and calculating the area under the curve (AUC), we comprehensively evaluated the overall diagnostic performance of TS in distinguishing between women with and without cervical lesions across different viral load levels. The closer the AUC value is to 1.0, the higher the accuracy of TS in classifying patients within that subgroup.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Affiliated Hospital of Nantong University | Nantong | Jiangsu |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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