Integrated human papillomavirus (HPV) DNA as individualized biomarker for the detection of recurrent cervical pre-cancer in post-treatment surveillance

• Conditions: D06.0; D06.1; Endocervix; Exocervix

• Registration Number: DRKS00010435
• Lead Sponsor: Klinik für Frauenheilkunde und GeburtshilfeAbteilung FrauenheilkundeUniversitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-02
• Study Completion: 2019-10-09
• Results First Posted: 2021-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 649

Inclusion Criteria

•Patients with histologic confirmed HPV16 or HPV18 positive CIN3
•Informed consent

Exclusion Criteria

•Re-conisation

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
False positive rate (FPR; 1 – specificity): proportion of test positives at the time point of 6 months after surgery in subjects without signs of recurrence for up to 24 post-treatment months

Secondary Outcome Measures

Name	Time	Method
• True positive rate (TPR; sensitivity): proportion of test positives at the time point of 6 months after surgery in subjects with signs of recurrence for up to 24 post-treatment months<br>• Positive and negative predictive values<br>• Follow-up performance, defined as true and false positive rates and predictive values of repeated index tests during follow-up <br>• Single test performance of cytology, hrHPV-test and vcj-PCR<br>• Prevalence of primary CIN3 with HPV16/18 DNA integration <br>• Proportion of positive subjects revealed by each index test