An observational study in Cervical Intraepithelial Neoplasia Grade 2, sponsored by European Institute of Oncology. Recruiting at 2 sites in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by European Institute of Oncology · Observational
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.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's planned enrollment of 100 is below the median of 470 across 96 observational studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
women with histological diagnosis of CIN2
Exclusion criteria:
wait-and-see strategy
surgical treatment per clinical practice
Evaluation of methylation of the host cell genes FAM19A4 and miR124-2
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. This test can identify patients with spontaneous regressing precancer lesions (negative result) from patients with a progressing precancer lesion (positive result).
Time frame: 6 months
Evaluation of clinical course of CIN2 at 2 years after diagnosis
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.
Time frame: 2 years
Evaluation of overall accuracy of PreCursor-M+
Overall accuracy, positive predictive value and negative predictive value of PreCursor-M+
Time frame: 6 months - 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
European Institute of Oncology