HPV Infections, Cancer of the Vulva and Therapeutical Success

Completed

• Conditions: Human Papilloma Virus; HPV
• Interventions: Diagnostic Test: polymerase chain reaction

• Registration Number: NCT03082950
• Lead Sponsor: University of Luebeck

Brief Summary

HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.

Detailed Description

HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.

After having retrospectively identified patients with vulvar cancer incl. their preinvasive lesions in the clinical registry the hpv status of the samples is prospectively analyzed using a new multiplex pcr Array. Two Groups are build: patients with hpv associated vulvar cancer and patients with non-hpv associated vulvar cancer.

Then, the rate of patients who respond to radiotherapy within the Groups is analyzed by building Kaplan meier plots according to the patients survival and recurrence rate.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2017-03-12
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-17
• Primary Completion: 2017-12
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• pts. who suffer from vulvar cancer and their preinvasive lesions
• positive informed consent
• complete set of data
• Treatment in luebeck university

Exclusion Criteria

• opposite of above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	polymerase chain reaction	human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions
2	polymerase chain reaction	non-human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions

Primary Outcome Measures

Name	Time	Method
prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions	15yrs

Secondary Outcome Measures

Name	Time	Method
disease free survival among the groups	15yrs

Trial Locations

Locations (1)

Luebeck University, Department for obstetrics and gynecology; 🇩🇪 Luebeck, Schleswig Holstein, Germany