This prospective, multicenter cohort study will recruit eligible HPV16/18-positive women from three tertiary hospitals in China. Peripheral blood samples and clinical data (cytology, HPV genotyping, colposcopy-directed biopsy) will be collected, followed by standardized mass cytometry (CyTOF) to develop and evaluate an immune model across cervical lesion grades.
This study aimed to validate the diagnostic efficacy of our previously established CyTOF-based immune model for identifying CIN3+ lesions (including CIN3 and cervical cancer) in a multicenter prospective cohort of HPV16/18-positive women. In addition, this study seeks to promote the standardized implementation of mass cytometry in cervical lesion triage, construct a non-invasive, high-throughput and high-accuracy immune diagnostic workflow, improve the diagnostic efficiency and precision management of HPV16/18-positive populations, and minimize unnecessary invasive examinations as well as patients' psychological burden. Ultimately, it is expected to advance the precision-oriented optimization of national cervical cancer prevention strategies. Meanwhile, the feasibility and clinical superiority of this model will be evaluated by comparing it with current mainstream screening modalities, such as cervical cytology, HPV genotyping and colposcopy-guided cervical biopsy, which lays a solid foundation for the subsequent development of related auxiliary diagnostic reagents and products.(1)Primary objective: To validate the diagnostic efficacy (sensitivity, specificity, area under the curve \[AUC\]) of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women.(2)Secondary objective: To validate the diagnostic efficacy (sensitivity, specificity, AUC) of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women, and to compare its accuracy, positive and negative predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy). (3)Exploratory objective: To investigate the adaptability and stability of the model across different populations (e.g., by age group and vaccination status).
Study Type
OBSERVATIONAL
Enrollment
1,465
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Time frame: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Time frame: through study completion, an average of 1 year
The diagnostic specificity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Time frame: through study completion, an average of 1 year
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women，
Time frame: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women
Time frame: through study completion, an average of 1 year
The diagnostic specificity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women
Time frame: through study completion, an average of 1 year
Compare the CyTOF-based immune model's accuracy with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)
Time frame: through study completion, an average of 1 year
Compare the CyTOF-based immune model's positive predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Compare the CyTOF-based immune model's negative predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)
Time frame: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN3+ lesions across subgroups(e.g., by age group and vaccination status)
Time frame: through study completion, an average of 1 year
Calibration Slope of the CyTOF-based immune model for detecting CIN3+ lesions across subgroups (e.g., by age group and vaccination status)
Time frame: through study completion, an average of 1 year