Cervical cancer, cervical intraepithelial neoplasia, and non cervical diseases with HPV16/18 infection.
Conditions
Interventions
Gold Standard:Colposcopy and pathological diagnosis of cervical biopsy
Index test:HPV E6/E7 mRNA detection (LAMP-LFA method)
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
25 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.>25 years of age, female; 2.Received vaginal HPV testing within the past 3 months, with confirmed 16/18 HPV infection status, and has not received anti HPV treatment; 3.Gynecological patients with clinically or pathologically confirmed cervical cancer, cervical intraepithelial neoplasia, or non cervical diseases; 4.Complete records of medical history and related test results; 5.With intact cervix; 6.Voluntarily participated in this study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1.Previous history of cervical conization or hysterectomy; 2.Previous history of pelvic and abdominal radiotherapy or chemotherapy; 3.History of other malignant tumors; 4.Severe intellectual disabilities or impairments, or unable to perform vaginal secretion self sampling or sign informed consent forms;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coincidence rate; | — |
Countries
China
Contacts
Public ContactZhu Tao
Zhejiang Cancer Hospital
Outcome results
None listed