Evaluation of the PreCursor-M+® in CIN2

Cervical Intraepithelial Neoplasia Grade 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06403618
• Other study ID #: UID 4438
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: May 15, 2027

Study information

• Verified date: April 2024
• Source: European Institute of Oncology
• Contact: Anna Daniela Iacobone
• Phone: +390294371088
• Email: annadaniela.iacobone[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia Grade 2
• Uterine Cervical Dysplasia

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 years
Secondary	Evaluation of overall accuracy of PreCursor-M+	Overall accuracy, positive predictive value and negative predictive value of PreCursor-M+	6 months - 2 years