Discovery of biomarkers in cervical smears for diagnosis and prognosis of cervical lesions

Phase 3

• Conditions: CIN leasions; premalignancy of cervical cancer; 10047438; 10038595

• Registration Number: NL-OMON51329
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 570

Inclusion Criteria

- Age>=18 years
- Signed informed consent
- Women did notno opt-out for making their smear available for research
- Women who undergo a colposcopy examination because of a positive HPV test and
an abnormal PAP-smear.
- Women in follow up after a radical vaginal trachelectomy
- Women diagnosed with cervical cancer

Exclusion Criteria

- Women who are pregnant during the colposcopy or surgery
- Women who are not able to understand the study-information
- Women whom did not signed informed consent.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>: The main study parameter is the difference in gene-expression profiles<br /><br>between cervical smears from healthy women and women with CIN1, CIN2, CIN3 and<br /><br>cancer lesions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The second objective is to evaluate how gene expression profiles in smears<br /><br>relate to gene expression profiles in matching dysplastic or cancer tissue. </p><br>