Cervical lesions
Conditions
Interventions
case series:NA
Sponsors
Obstetrics and Gynecology Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Informed consent, voluntary signing of informed consent; 2. The subjects who have the results of cervical cytology and/or HPV test in the past 1 year; 3. It conforms to the "China's Expert Consensus on Cervical Cancer Screening and Abnormal Management (II)" and the patients with abnormal cervical cancer screening and indications for colposcopy.
Exclusion criteria
Exclusion criteria: 1. Pregnant women; 2. According to the menstrual cycle, it is not appropriate to perform colposcopy or cervical lesion tester during the examination period; 3. Irremovable, excessive cervical mucus or secreta caused by inflammation, bacterial infection or other reasons, which may affect the results of cervical lesion tester or colposcopy; 4. The cervix has cauliflower-like ulcer visible to the naked eye or obviously a mass of cervical cancer; 5. The subjects who have done radiotherapy for urogenital system in the past; 6. The subjects who have undergone cervical resection; 7. Congenital abnormal anatomy of cervix and vagina (for example, double cervix); 8. Abnormal anatomical position of cervix, such as extreme anteversion or retroversion of uterus; 9. The subjects with incomplete cervical exposure; 10. Severe vaginal atrophy or excessive vaginal relaxation; 11. Severe laceration of cervix; 12. The diameter of the cervical surface is obviously smaller than or larger than the diameter of the examination catheter (2.9cm); 13. Suffering from acute genital tract infection; 14. There may be other serious bleeding risks during the examination; 15. The subjects with a history of iodine allergy; 16. The subjects with a history of photosensitive diseases or other diseases caused by ultraviolet radiation (for example: porphyria, lupus erythematosus); 17. The subjects who are undergoing phototherapy; 18. The subjects who have used photosensitizers within the last week, such as fluoroquinolones or retinoids; 19. Systemic important organ dysfunction, such as heart failure and severe hepatic and renal insufficiency; 20. The subjects who have sex within 72 hours before colposcopy, or have vaginal irrigation and medication; 21. The subjects who have participated in other clinical trials within 1 month before screening; 22. The researcher thinks it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| accuracy;Positive predictive value;Comparison of sensitivity and negative predictive value between cervical lesion tester and colposcopy; | — |
Countries
China
Contacts
Public ContactLong Sui
Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed