Evaluation of the PreCursor-M+® Assay Performance in the Management of Women Diagnosed With CIN2

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
View:

• 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;

• written informed consent given.

Locations
Other Locations
Italy
European Institute of Oncology
NOT_YET_RECRUITING
Milan
European Institute of Oncology, Milan,
RECRUITING
Milan
Contact Information
Primary
Anna Daniela Iacobone
annadaniela.iacobone@ieo.it
+39 0294371088
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2027-06-17
Participants
Target number of participants: 100
Treatments
active surveillance
wait-and-see strategy
immediate treatment
surgical treatment per clinical practice
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov