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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 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active surveillance | wait-and-see strategy | ||
| immediate treatment | surgical treatment per clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 \ |
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Inclusion Criteria:
Exclusion criteria:
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women with histological diagnosis of CIN2
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Daniela Iacobone | Contact | +39 0294371088 | annadaniela.iacobone@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Anna Daniela Iacobone | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology, Milan, | Recruiting | Milan | 20141 | Italy |
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collection of liquid based cervical samples
| 2 years |
| Evaluation of overall accuracy of PreCursor-M+ | Overall accuracy, positive predictive value and negative predictive value of PreCursor-M+ | 6 months - 2 years |
| European Institute of Oncology | Not yet recruiting | Milan | Italy |
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