Evaluation of the PreCursor-M+® in CIN2

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the PreCursor-M+® test, which looks at certain genetic changes in cervical cells to help understand the development of a condition called Cervical Intraepithelial Neoplasia Grade 2 (CIN2). CIN2 is a precancerous change in the cervix that can sometimes progress to more serious conditions. The trial aims to see how well this test works in predicting whether CIN2 will improve, stay the same, or worsen over a two-year period. Women involved will either be monitored closely without immediate treatment or will receive treatment right away, depending on their test results.

To be eligible for this trial, women need to be 18 years or older and have a confirmed diagnosis of CIN2 from a recent biopsy. They must also have a known result from a test that checks for human papillomavirus (HPV), a virus linked to cervical cancer. Participants will have their health tracked over two years, with check-ins every six months to see how their condition changes. This trial is not yet recruiting participants, but it is an important step in finding better ways to manage CIN2.

Gender

FEMALE

Eligibility 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.