Testing for HPV and TSLC1 silencing as marker for the risk assessment of cervical cancer

• Conditions: high-grade premalignant cervical lesions; high-grade cervical intraepithelial neoplasia; 10038588

• Registration Number: NL-OMON29859
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 82

Inclusion Criteria

-Female
-Age 20-70
-Previous two Pap smears read as bordeline/mild dyskaryosis (Pap2/3a1) or previous single Pap smear read as moderate dyskaryosis or worse (*Pap3a2)
-Intact cervix (no history of treatment involving damage to the transformation zone of the cervix)
- Sufficient knowledge of the Dutch language.
- Able to understand the content of the study (according to the gynecologist).
- Signed informed consent form.

Exclusion Criteria

-Pap smear read as Pap 5 (suspect for invasive cancer)
-Cancer at other sites
-Withdrawal of permission by the patient
-History of surgery on the cervix
-Pregnancy or pregnant in the last 3 months.
-Breast-feeding, or breast-feeding in the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the frequency of CIN3 in two study populations,<br /><br>i.e. women who test positive for hrHPV and TSLC1 compared with women who test<br /><br>negative for either or both hrHPV and TSLC1. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As one of the secondary parameters it will be assessed whether the CIN3 lesions<br /><br>are advanced lesions. This will be evaluated by measuring the size of the<br /><br>lesions using colposcopic imaging and the status of molecular markers for<br /><br>advanced CIN3 (a.o. elevated hTERT mRNA expression levels) in the lesions.</p><br>