Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-06-17
2027-06-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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active surveillance
wait-and-see strategy
No interventions assigned to this group
immediate treatment
surgical treatment per clinical practice
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. vulnerable patients.
18 Years
FEMALE
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Anna Daniela Iacobone
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
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European Institute of Oncology, Milan,
Milan, , Italy
European Institute of Oncology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Anna Daniela Iacobone
Role: primary
Other Identifiers
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UID 4438
Identifier Type: -
Identifier Source: org_study_id
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