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Accuracy verification study of self-sampled HPV E6/E7 mRNA and HPV DNA tests

Accuracy verification study of self-sampled HPV E6/E7 mRNA and HPV DNA tests

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069265
Enrollment
Unknown
Registered
2023-03-10
Start date
2021-11-19
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

Gold Standard:histopathologic biopsy
Index test:self-sampled HPV E6/E7 mRNA and HPV DNA test clinician-sampled HPV E6/E7 mRNA and HPV DNA test

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. The patients who visited the hospital (outpatient or inpatient department) understood the study procedure and participated voluntarily. 2. Aged 21-69 years, had sex. 3. Meet the conditions of two samples at the same time, and can sample by herself. 4. No sex, vaginal lavage and drug use 3 days before sampling.

Exclusion criteria

Exclusion criteria: 1. Subjects with incomplete information. 2. Had cervical surgery, more than 1/3 of the cervix was removed. 3. Had a history of pelvic radiation therapy. 4. Pregnant subjects.

Design outcomes

Primary

MeasureTime frame
Diagnostic performance (sensitivity, specificity, accuracy);—

Secondary

MeasureTime frame
Positive rate;Detection consistency (positive coincidence rate, negative coincidence rate, total coincidence rate);Factors;—

Countries

China

Contacts

Public ContactHan Liping
hanliping0825@163.com+86 136 1984 5906

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026