Evaluation of the PreCursor-M+® in CIN2
Recruiting now
Conditions studied: Cervical Intraepithelial Neoplasia Grade 2
In brief
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.
Key facts
- Study ID
- NCT06403618
- Run by
- European Institute of Oncology
- People needed
- 100
- Starts
- 2024-06-17
- Expected to finish
- 2027-06-17
- Last updated by the study team
- 2025-05-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- unknown HPV test result at diagnosis;
- vulnerable patients.
Where it is running
- European Institute of Oncology, Milan, — Milan, Italy (enrolling)
- European Institute of Oncology — Milan, Italy
Full record on ClinicalTrials.gov
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