Cervical disease
Conditions
Interventions
Gold Standard:After completion of colposcopy, clinical diagnosis results (such as colposcopy list, etc.) and pathological results (if any) of enrolled subjects were collected to establish a gold stand
Positive diagnosis results must be accompanied by pathological examination reports, including CIN1, CIN2, CIN3, AIS (adenocarcinoma in situ), squamous cell carcinoma and adenocarcinoma. Negative diagn
Expert group composition requirements: 3 people, deputy chief physician and above. First, two experts were evaluated back to back, and if the results were consistent, the output was the gold standard
If the results are inconsistent, the arbitration expert (the third expert) will evaluate the results of the arbitration expert as the gold standard.
Index test:Sensitivity and specificity of cervical lesion diagnosis in experimental group (software-assisted investigator reading) and control group (investigator independent reading)
Accuracy, negati
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: ?18 years old = age =64 years old, sexual life history of women; ?It has an intact cervix; ?Conform to colposcopy criteria, plan to undergo colposcopy (Conform to one of these criteria): 1)Abnormal cervical cancer screening:a)ytology ASC-US with hr-hpv infection;b)Cytology LSIL and more serious; c)hr-hpv16/18 infection;d)hr-hpv infection persists for more than one year; 2)Symptoms or signs suggest suspected cervical cancer, abnormal bleeding in the lower genital tract, bleeding after repeated intercourse, or unexplained vaginal drainage; ?Volunteer to participate in the trial and sign the informed consent; ?Having full capacity for civil conduct.
Exclusion criteria
Exclusion criteria: ? There is a history of sexual life, vaginal irrigation, and vaginal medication 48 hours before the examination; ? History of cervical surgery (including cervical conectomy, hysterectomy, cervical physical therapy and chemoradiation, etc.); ? Pregnant women; (4) Colposcopic images are not clear, affecting interpretation; ? Participate in other clinical trials have not been out of the group; ? Researchers believe that it is not suitable for inclusion (such as colposcopy is not satisfied, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of cervical lesion diagnosis in experimental group (software-assisted investigator reading) and control group (investigator independent reading); | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy, negative predictive value and positive predictive value of experimental group (software-assisted researcher reading) and control group (researcher independent reading);Sensitivity and specificity of software independent film reading results;The test software recommended the accuracy of the biopsy site location;Test software performance evaluation; | — |
Countries
China
Contacts
Public ContactLan.Zhu
Peking Union Medical College Hospital
Outcome results
None listed