Biomarkers Predictive for Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Evolvement

Launched by UNIVERSITY OF AARHUS · Sep 9, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how a specific tissue biomarker called HPV E4 can help predict which women with a diagnosis of Cervical Intraepithelial Neoplasia Grade 2 (CIN2) might experience progression to more severe conditions, like CIN3 or cervical cancer. CIN2 is a moderate grade of cell changes in the cervix that can sometimes go back to normal but can also lead to more serious issues. The goal of the study is to find out if testing for HPV E4 can help doctors better manage these patients by identifying who might need immediate treatment versus those who can be safely monitored over time.

To participate in this study, women aged 23-40 who were diagnosed with CIN2 between 2000 and 2010 and have been managed with active surveillance (meaning they have not had surgery within four months of their diagnosis) may be eligible. Participants can expect to have their cervical samples analyzed to see if they are HPV E4 positive or negative, which could give insights into their risk of disease progression. This research is important as it aims to improve how women with CIN2 are treated, potentially leading to better outcomes and less unnecessary surgery.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women
• • 23-40 years of age
• • First record of CIN2 verified diagnosis (M74B09, T83110)
• • Managed by active surveillance (i.e. no surgical treatment within 4 months after index CIN2 diagnosis)
• • Record of CIN2 diagnosis during 2000-2010 and at least one record of cervix histological sample during follow-up.
• Exclusion Criteria:
• • Prior record of CIN2+ (i.e. CIN2, CIN3, cervical cancer), hysterectomy or cervical excisional cone biopsy.
• • No record of cervical histological sample (cervical punch biopsy of cervical excisional biopsy) within two years after index CIN2 diagnosis.