Condition: Cervical Intraepithelial Neoplasia Grade 2 · Sponsor: European Institute of Oncology
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.
This description comes directly from the study's public registry record.
Anna Daniela Iacobone · +39 0294371088 · annadaniela.iacobone@ieo.it
Always discuss trial participation with your own doctor first.
| European Institute of Oncology, Milan, | Milan, Italy | Recruiting |
| European Institute of Oncology | Milan, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06403618