Evaluation of the PreCursor-M+® in CIN2

NCT06403618 | Recruiting

• 1 other identifier: UID 4438
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cervical Intraepithelial Neoplasia Grade 2

Outcome Measures

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).

  6 months

Secondary Outcomes (2)

• Evaluation of clinical course of CIN2 at 2 years after diagnosis

  2 years

• Evaluation of overall accuracy of PreCursor-M+

  6 months - 2 years

Study Arms (2)

active surveillance

wait-and-see strategy

immediate treatment

surgical treatment per clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women with histological diagnosis of CIN2

You may qualify if:

• 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.

You may not qualify if:

• unknown HPV test result at diagnosis;
• vulnerable patients.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (2)

European Institute of Oncology, Milan,

Milan, 20141, Italy

RECRUITING

European Institute of Oncology

Milan, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

collection of liquid based cervical samples

Study Officials

• Anna Daniela Iacobone

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Daniela Iacobone

CONTACT

+39 0294371088; annadaniela.iacobone@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: June 17, 2024
• Primary Completion: June 17, 2025
• Study Completion (Estimated): June 17, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

IT (2)