Evaluation of the PreCursor-M+® in CIN2

Cervical Intraepithelial Neoplasia Grade 2 Clinical Trial

Official title: Evaluation of the PreCursor-M+® Assay Performance in the Management of Women Diagnosed With CIN2

Status Not yet recruiting

Clinical Trial Summary

The goal of this observational study is to to evaluate the accuracy and sensitivity of PreCursor-M+ on a post-aliquot of liquid-based cytology (LBC) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of CIN2. The PreCursor-M+® assay is a multiplex real-time methylation specific PCR test that identifies the level of promotor methylation of the host cell genes FAM19A4 and miR124-2, known biomarkers associated with cervical carcinoma and transforming CIN in cervical cells. To evaluate the clinical course of CIN2 at 2 years after the first diagnosis, with an interval evaluation at 6 months. After enrolment, women will be divided into two groups: "active surveillance" and "immediate treatment". In the first group, clinical outcomes to be assessed, in relation to the PreCursor-M+ result at baseline, will include regression to <CIN2, persistence of CIN2, and progression to CIN3+. In the second group, we will evaluate the histological diagnosis at cone specimen (downgrading or upgrading) and the 2-year cumulative incidence of CIN2+ recurrence based on the PreCursor-M+ result at baseline.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia Grade 2
• Uterine Cervical Dysplasia

• NCT number: NCT06403618
• Study type: Observational
• Source: European Institute of Oncology
• Contact: Anna Daniela Iacobone
• Phone: +390294371088
• Email: annadaniela.iacobone@ieo.it
• Status: Not yet recruiting
• Start date: May 15, 2024
• Completion date: May 15, 2027