Clinical trial · Observational
Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
Mass Cytometry-based Peripheral Blood Immune Model for Accurate Detection of Cervical Lesions in HPV16/18-positive Women: a Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer (Early Detection) | Malignant Cervical Neoplasm | CURATED_EXACT | 0.85 |
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
- timeFrame
- through study completion, an average of 1 year
- measure
- AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
- timeFrame
- through study completion, an average of 1 year
- measure
- The diagnostic specificity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
- timeFrame
- through study completion, an average of 1 year
Secondary outcomes (8)
- measure
- The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women，
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available