Cervical Cancer (Early Detection), CIN 2/3
Conditions
Keywords
cervical cancer, Cervical Intraepithelial Neoplasia, HPV16/18, Mass cytometry, Immune model
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Jiaxing Maternity and Child Health Care Hospital
Ningbo Women & Children's Hospital
Zhejiang PuLuoTing Health Technology Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Availability of cervical cytology results * Consent to colposcopy and cervical biopsy * Signed informed consent
Exclusion criteria
* 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 * Pregnancy or lactation * Inability to comply with follow-up and examinations * Inability to comply with study procedures, restrictions, and requirements, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women | through study completion, an average of 1 year |
| AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women | 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 | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women， | through study completion, an average of 1 year |
| AUC of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women | 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 | 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) | 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) | through study completion, an average of 1 year |
| 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) | 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) | 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) | through study completion, an average of 1 year |
Contacts
CONTACTJunfen Xu
Outcome results
None listed