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NCT Number: NCT03082950

HPV Infections, Cancer of the Vulva and Therapeutical Success

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.

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Key information

Conditions

HPV Human Papilloma Virus

Sex eligibility

Female

Study type

Observational

Primary location

Luebeck University, Department for obstetrics and gynecology

Lübeck, Schleswig-Holstein, D-23538, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymerase chain reaction

Diagnostic Test

PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.

Other names: EUROARRAY

Primary outcomes

  1. prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions

    Time frame: 15yrs

Secondary outcomes

  1. disease free survival among the groups

    Time frame: 15yrs

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • EUROIMMUN Medizinische Labordiagnostika AG

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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