Evaluation of the PreCursor-M+® in CIN2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Intraepithelial Neoplasia Grade 2. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the PreCursor-M+® Assay Performance in the Management of Women Diagnosed With CIN2
Overview
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.
Primary outcome measures
- Evaluation of methylation of the host cell genes FAM19A4 and miR124-2 [Time frame: 6 months]
Secondary outcome measures (2)
- Evaluation of clinical course of CIN2 at 2 years after diagnosis [Time frame: 2 years]
- Evaluation of overall accuracy of PreCursor-M+ [Time frame: 6 months - 2 years]
Eligibility criteria
Inclusion criteria
- age at diagnosis of 18 years or older;
- histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization;
- known HPV test result at baseline;
- ability to understand and sign the informed consent;
- written informed consent given.
Exclusion criteria
- unknown HPV test result at diagnosis;
- vulnerable patients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Italy · 2 centers
- European Institute of Oncology, Milan, — Milan
- European Institute of Oncology — Milan
Identifiers
NCT: NCT06403618 · UID 4438