Cervical Lesions
Conditions
Interventions
Gold Standard:Biopsy pathological findings
Index test:Intrinsic Fluorescence Image-diagnostic Apparatus for Cervical Lesions
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: (1) Female with sexual life history, aged 60 years old or less; (2) Women with cervical TCT results of >= ASC-US-H) and/or HPV16/18(+) who need to be referred for colposcopy, or women with previous cervical lesions requiring colposcopy reexamination; (3) Understand the test situation and be willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Acute stage of vaginal inflammation; (2) lesions easy to bleed, uterine bleeding and other conditions affecting the observation; (3) pregnancy or postpartum 6 months or menstruating women (menstruating and menstruation within three days); (4) Within three months of radiotherapy for pelvic malignancy, within three months of receiving photodynamic therapy or photodynamic therapy, within three months of suffering from photosensitive diseases (such as porphyria, systemic lupus erythematosus); (5) History of uterine body and cervix resection; (6) Cervical epithelial type III transformation area; (7) Vaginal drug use within 3 days before the examination; (8) Situations considered unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity in the diagnosis of cervical lesions;specificity in the diagnosis of cervical lesions;positive predictive values in the diagnosis of cervical lesions;negative predictive values in the diagnosis of cervical lesions; | — |
Countries
China
Contacts
Public ContactJianhua Liu
Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed