Clinical trial NCT03082950: HPV Infections, Cancer of the Vulva and Therapeutical Success
Official title: Influence of Hpv Infections on Therapeutical Outcome of Patients Suffering From Vulvar Cancer and Ist Preinvasive Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV
Human Papilloma Virus
Keywords: hpv prevalence
recurrence rate
survival
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: EUROIMMUN Medizinische Labordiagnostika AG
First posted: 2017-03-17
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions
timeFrame: 15yrs
Secondary outcomes:
measure: disease free survival among the groups
timeFrame: 15yrs
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Luebeck University, Department for obstetrics and gynecology
state: Schleswig Holstein
Study officials:
affiliation: Westpfalz-Klinikum
name: Daniel Beyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.
citation: Sri T, Merideth MA, Pulanic TK, Childs R, Stratton P. Human papillomavirus reactivation following treatment of genital graft-versus-host disease. Transpl Infect Dis. 2013 Aug;15(4):E148-51. doi: 10.1111/tid.12098. Epub 2013 May 28.
citation: Nocon M, Mittendorf T, Roll S, Greiner W, Willich SN, von der Schulenburg JM. Review on the medical and health economic evidence for an inclusion of colposcopy in primary screening programs for cervical cancer. GMS Health Technol Assess. 2007 Aug 10;3:Doc07.