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.
Availability of cervical cytology results
Consent to colposcopy and cervical biopsy
Signed informed consent
Confirmed diagnosis of CIN2 or worse
Prior cervical ablation, cervical conization, chemoradiotherapy, or immunotherapy
Other malignancy within the past 2 years not in complete remission
Presence of other systemic immune disease or active infection
HPV16/18-positive patients
Cohort
Prospective
Not listed
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
The diagnostic specificity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women，
AUC of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women
The diagnostic specificity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women
Compare the CyTOF-based immune model's accuracy with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Jiaxing Maternity and Child Health Care Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Zhejiang PuLuoTing Health Technology Co., Ltd.
Collaborator
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