Evaluation of the PreCursor-M+® in CIN2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age at diagnosis of 18 years or older;
histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization;
known HPV test result at baseline;
ability to understand and sign the informed consent;
Disqualifiers
unknown HPV test result at diagnosis;
vulnerable patients.
Trial population
women with histological diagnosis of CIN2
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: active surveillance
Group B: immediate treatment
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 years2
Evaluation of overall accuracy of PreCursor-M+
Overall accuracy, positive predictive value and negative predictive value of PreCursor-M+
Time frame
6 months - 2 yearsSponsors and contacts
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Source ClinicalTrials.gov