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Evaluation of the PreCursor-M+® in CIN2

NCT06403618 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-05-23

No results posted yet for this study

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

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Anna Daniela Iacobone · European Institute of Oncology

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-06-17
Completion
2027-06-17

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06403618 on ClinicalTrials.gov