Cervical cancer
Conditions
Interventions
Gold Standard:The results of the cytology expert group were selected as the gold standard. The participating center will designate one clinical cytology expert (definition of expert: associate chief p
Index test:Cervical fluid-based cytology image-assisted diagnostic software
Sponsors
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 (including 18-75); 2) Subjects requiring liquid-based cytology; 3) The subject will voluntarily participate and sign the informed consent after the informed consent; Cervical liquid based cytology slides: 1) The background is clean and the cells are evenly spread; 2) Good cell fixation and intact cell morphology; 3) The total number of squamous cells in the entire slice is greater than 5000; 4) The chromatin in the nucleus is clear and granular; 5) No large amount of blood, mucus, or inflammatory cells covering; 6) No artificial illusion, no drying phenomenon; 7) No dry sealing phenomenon; No environmental reagent impact; 8) No overflow of sealing adhesive, no damage, and no marking with a marker pen. Cervical fluid based cytology images: 1) Specify the image scanned by the digital scanner; 2) Cervical fluid based cytology images with good reliability.
Exclusion criteria
Exclusion criteria: 1) Persons who do not have full capacity for civil conduct; 2) Patients with a history of hysterectomy and cervical conectomy; 3) Subjects of childbearing age who test positive for pregnancy; 4) Lactating subjects; 5) menstruating subjects; 6) Subjects with a history of pelvic radiotherapy; 7) Subjects with a history of chemotherapy; 8) Subjects with asexual life history; 9) Subjects with critical and severe diseases; 10) Participants who have participated in clinical trials or are participating in other clinical trials within the past three months; 11) Participants considered unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Independent diagnostic accuracy of software;Film reading efficiency;Positive predictive value, negative predictive value; | — |
Countries
China
Contacts
Public ContactZHU Lan
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Outcome results
None listed