Actively Recruiting
Evaluation of the PreCursor-M+® in CIN2
Led by European Institute of Oncology · Updated on 2025-05-23
100
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the PreCursor-M+® in CIN2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at diagnosis
- Histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment including LEEP and laser conization
- Known HPV test result at baseline
- Ability to understand and sign informed consent
- Written informed consent given
You will not qualify if you...
- Unknown HPV test result at diagnosis
- Vulnerable patients
AI-Screening
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Trial Site Locations
Total: 2 locations
1
European Institute of Oncology, Milan,
Milan, Italy, 20141
Actively Recruiting
2
European Institute of Oncology
Milan, Italy
Not Yet Recruiting
Research Team
A
Anna Daniela Iacobone
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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