The goal of this observational study is to to evaluate the accuracy and sensitivity ofPreCursor-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 thatidentifies the level of promotor methylation of the host cell genes FAM19A4 and miR124-2,known biomarkers associated with cervical carcinoma and transforming CIN in cervicalcells.To evaluate the clinical course of CIN2 at 2 years after the first diagnosis, with aninterval 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 relationto the PreCursor-M+ result at baseline, will include regression to
Not Provided
Inclusion Criteria:
1. age at diagnosis of 18 years or older;
2. histological confirmation of CIN2 after colposcopic-guided cervical biopsy or
conservative surgical treatment, including loop electrosurgical excision procedure
(LEEP) and laser conization;
3. known HPV test result at baseline;
4. ability to understand and sign the informed consent;
5. written informed consent given.
Exclusion criteria:
1. unknown HPV test result at diagnosis;
2. vulnerable patients.
European Institute of Oncology
Milan, Italy
Investigator: Anna Daniela Iacobone
Anna Daniela Iacobone
+390294371088
annadaniela.iacobone@ieo.it
Anna Daniela Iacobone, Principal Investigator
European Institute of Oncology