Evaluation of the PreCursor-M+® in CIN2

European Institute of Oncology

Status: Enrolling

Conditions: Cervical Intraepithelial Neoplasia Grade 2

Study type: Observational

Funder types: Other

Identifiers

NCT06403618

UID 4438

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

active surveillance

Description:

wait-and-see strategy

immediate treatment

Description:

surgical treatment per clinical practice