Cervical lesion
Conditions
Interventions
Gold Standard:Colposcopy and/or histopathological biopsy were performed according to the conventional diagnosis and treatment procedures, with histopathological diagnosis as the gold standard.
Index test:1.The results of HPV E6/E7 mRNA detection by patient in cervical exfoliated cells self-sampling.
2. The results of HPV E6/E7 mRNA detection by physician in cervical exfoliated cells self-s
Sponsors
Obstetrics and Gynecology Hospital, Fudan University
Eligibility
Sex/Gender
Female
Age
21 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients (outpatient or inpatient), aged 21-69 years, voluntarily enrolled in the clinical trial; 2. Able to meet the conditions of sampling twice at the same time, and able to self-sampling: no examination to reduce cervical shedding cells has been done within a month.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of pelvic radiation and chemotherapy, who have undergone cervical surgery within 1 month, and who have undergone total hysterectomy; 2. Women who have had vaginal irrigation, vaginal medication, or sexual intercourse within 72 hours prior to cervical test sample collection; 3. Patients who have been diagnosed with cervical cancer; 4. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV E6/E7 mRNA;Accuracy, Specificity, Sensitivity; | — |
Countries
China
Contacts
Public ContactLong Sui
Obstetrics and Gynecology Hospital, Fudan University
Outcome results
None listed