Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CIN 2/3, Cervical Cancer (Early Detection). Basic parameters: 25 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mass Cytometry-based Peripheral Blood Immune Model for Accurate Detection of Cervical Lesions in HPV16/18-positive Women: a Multicenter Study
Overview
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).
Primary outcome measures
- 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]
Secondary outcome measures (8)
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07606677 · IRB-20260080-R