Clinical Research Directory

Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia

Sponsor: Lund University

Summary

The goal of this observational study (retrospective cohort study) is to determine whether DNA methylation status in archived cervical cytology samples can predict regression, persistence, or progression of high-grade cervical dysplasia (HSIL/CIN2-3) in women who have previously undergone clinical management and follow-up. The main questions it aims to answer are: Can methylation status in archived cervical cytology samples predict histologic regression of HSIL (CIN2/3)? Does the addition of clinical factors, screening history, smoking status, and HPV genotype improve the predictive ability of methylation markers for disease regression, persistence, or progression? Researchers will compare: Women whose lesions regressed with women whose lesions persisted or progressed. Methylation-positive and methylation-negative samples to assess whether methylation status is associated with subsequent clinical outcomes. Participants will: Be identified retrospectively from women aged 23 to 70 years who were previously diagnosed with HSIL/CIN2-3 and managed according to routine clinical practice. Have archived cervical cytology samples retrieved from biobanks for DNA methylation analysis. Contribute existing clinical, cytological, histological, and HPV data collected during routine care. Contribute existing follow-up data from medical records, including outcomes such as regression, persistence, progression, and treatment results. No additional interventions, testing, or follow-up visits will be performed as part of the study; all analyses will be based on retrospectively collected biological samples and clinical data.

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