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Evaluation of the PreCursor-M+® in CIN2

Recruitingn/aAges 18 Years - anyFemaleEuropean Institute of Oncology
NCT06403618 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, pe

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
European Institute of Oncology, Milan,
Milan, Italy
European Institute of Oncology
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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