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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010435

Enrollment

670

Registered

2016-05-02

Start date

2016-05-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D06.0 D06.1

Interventions

Group 1: The HPV-INT-CX study is a prospective multicentre observational trial. The trial will adhere to the schedule proposed by current monitoring guidelines following CIN3 surgery. The total survei

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • Re-conisation

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• 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 • Positive and negative predictive values • Follow-up performance, defined as true and false positive rates and predictive values of repeated index tests during follow-up • Single test performance of cytology, hrHPV-test and vcj-PCR • Prevalence of primary CIN3 with HPV16/18 DNA integration • Proportion of positive subjects revealed by each index test	—

Measure

Time frame

• 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 • Positive and negative predictive values • Follow-up performance, defined as true and false positive rates and predictive values of repeated index tests during follow-up • Single test performance of cytology, hrHPV-test and vcj-PCR • Prevalence of primary CIN3 with HPV16/18 DNA integration • Proportion of positive subjects revealed by each index test

—

Countries

Germany

Contacts

Public ContactMatthias Dürst

Klinik für Frauenheilkunde und GeburtshilfeAbteilung FrauenheilkundeUniversitätsklinikum Jena

matthias.duerst@med.uni-jena.de03641933720

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026