Evaluating a test for cervical pre-cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.