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Clinical Trials in Italy / NCT06403618
Recruiting Observational

Evaluation of the PreCursor-M+® in CIN2

NCT06403618 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Observational
Started
2024-06-17
Last updated
2025-05-23

Condition(s) studied

Cervical Intraepithelial Neoplasia Grade 2

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. age at diagnosis of 18 years or older; 2. histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization; 3. known HPV test result at baseline; 4. ability to understand and sign the informed consent; 5. written informed consent given. Exclusion criteria: 1. unknown HPV test result at diagnosis; 2. vulnerable patients.

Primary outcome measure(s)

  • Evaluation of methylation of the host cell genes FAM19A4 and miR124-2 — 6 months
    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. This test can identify patients with spontaneous regressing precancer lesions (negative result) from patients with a progressing precancer lesion (positive result).

Trial sites (2)

FacilityCityRegionStatus
European Institute of Oncology, Milan, Milan Italy Recruiting
European Institute of Oncology Milan Italy Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06403618 on ClinicalTrials.gov ↗ ← All trials in Italy