RecruitingNCT06403618

Evaluation of the PreCursor-M+® in CIN2

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


Sponsor

European Institute of Oncology

Enrollment

100 participants

Start Date

Jun 17, 2024

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a diagnostic device called PreCursor-M+ to assess its ability to predict outcomes in patients diagnosed with CIN2 — a moderate-grade precancerous cell change in the cervix — and to help guide treatment decisions. **You may be eligible if...** - You are 18 or older and have been diagnosed with CIN2 (moderate cervical cell changes) confirmed by biopsy or a loop excision/laser procedure - Your HPV (human papillomavirus) test result at diagnosis is known - You are able to understand and sign an informed consent form **You may NOT be eligible if...** - Your HPV test result at diagnosis is not available - You are considered a vulnerable patient (as defined by the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

European Institute of Oncology, Milan,

Milan, Italy

European Institute of Oncology

Milan, Italy

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NCT06403618