HPV Infections, Cancer of the Vulva and Therapeutical Success

May 2, 2018 updated by: Daniel Alexander Beyer, University of Luebeck

Influence of Hpv Infections on Therapeutical Outcome of Patients Suffering From Vulvar Cancer and Ist Preinvasive Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig Holstein
      • Luebeck, Schleswig Holstein, Germany, D-23538
        • Luebeck University, Department for obstetrics and gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pts. who suffer from vulvar cancer and their preinvasive lesions who were treated in luebeck University medical Center over a 15 year period

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions
Diagnostic test: polymerase chain reaction
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
Other Names:
  • EUROARRAY
2
non-human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions
Diagnostic test: polymerase chain reaction
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
Other Names:
  • EUROARRAY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions
Time Frame: 15yrs
15yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival among the groups
Time Frame: 15yrs
15yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

EUROIMMUN Medizinische Labordiagnostika AG

Investigators

  • Principal Investigator: Daniel Beyer, MD, Westpfalz-Klinikum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 12, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-15-220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HPV

Clinical Trials on polymerase chain reaction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe