Evaluating a test for cervical pre-cancer
Evaluation of the PreCursor-M+® Assay Performance in the Management of Women Diagnosed With CIN2
This study is testing a new test called PreCursor-M+ to see if it can accurately identify changes in cervical pre-cancer in women with CIN2, while they are monitored over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Trial ID | NCT06403618 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the accuracy and sensitivity of the PreCursor-M+ assay on liquid-based cytology samples from women diagnosed with Cervical Intraepithelial Neoplasia Grade 2 (CIN2). Participants will be monitored over two years, with evaluations at six-month intervals, and will be divided into two groups: one receiving active surveillance and the other undergoing immediate treatment. The study will analyze clinical outcomes based on the PreCursor-M+ results, including regression, persistence, or progression of CIN2. The assay focuses on detecting specific methylation patterns in genes associated with cervical cancer.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a histological confirmation of CIN2.
Not a fit: Patients with unknown HPV test results or those considered vulnerable may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment decisions for women diagnosed with CIN2.
How similar studies have performed: Other studies have shown promise in using methylation markers for cervical cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan and 1 other locations
- European Institute of Oncology, Milan, — Milan, Italy (Recruiting)
- European Institute of Oncology — Milan, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Anna Daniela Iacobone — European Institute of Oncology
- Study coordinator: Anna Daniela Iacobone
- Email: annadaniela.iacobone@ieo.it
- Phone: +39 0294371088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.