Cervical Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions, Uterine Cervical Cancer
Conditions
Brief summary
The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study. The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining. In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.
Interventions
Photoelectric detection was carried out on the subjects of the experimental group.
Sponsors
Lei Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity. * 2\. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US. * 3\. Fully informed and agreed to participate in the study. * 4\. No history of cervical cancer disease and cancer in other parts.
Exclusion criteria
* 1\. Cannot meet all Inclusion Criteria. * 2\. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。 * 3\. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions. | Enrolled subjects receive histopathological results approximately 7 days after colposcopy. | Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings. |
| Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector. | Enrolled subjects receive histopathological results approximately 7 days after colposcopy. | The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared between the fluorescence photoelectric technology and HPV detection results and cytology results, and the consistency and coincidence between the fluorescence photoelectric technology and HPV detection results and cytology results were calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation between fluorescence photoelectric technology and HPV detection and cytology results. | Enrolled subjects receive histopathological results approximately 7 days after colposcopy. | The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of HPV detection and cytology. |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed