NCT06403618

Evaluation of the PreCursor-M+® in CIN2

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2

Timeline

• Start date: 2024-06-17
• Primary completion: 2025-06-17
• Completion: 2027-06-17
• First posted: 2024-05-08
• Last updated: 2025-05-23

Locations

2 sites across 1 country: Italy