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NCT07777094
TS Triage of HR-HPV Positive Population and Its Accuracy Study
Conditions: Cervical Precancerous Lesions, Cervical Cancer
Sex: Female
Healthy volunteers: Yes
Enrollment: 300
Sponsor: Affiliated Hospital of Nantong University
Location: Affiliated Hospital of Nantong University Nantong Jiangsu
Summary
A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07777094). StuddyBuddy aggregates publicly available trial information.