HPV Infections, Cancer of the Vulva and Therapeutical Success
NCT ID: NCT03082950
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2015-10-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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1
human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions
polymerase chain reaction
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
2
non-human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions
polymerase chain reaction
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
Interventions
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polymerase chain reaction
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* positive informed consent
* complete set of data
* Treatment in luebeck university
Exclusion Criteria
FEMALE
No
Sponsors
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EUROIMMUN Medizinische Labordiagnostika AG
UNKNOWN
University of Luebeck
OTHER
Responsible Party
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Daniel Alexander Beyer
University of Luebeck
Principal Investigators
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Daniel Beyer, MD
Role: PRINCIPAL_INVESTIGATOR
Westpfalz-Klinikum
Locations
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Luebeck University, Department for obstetrics and gynecology
Lübeck, Schleswig-Holstein, Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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HL-15-220
Identifier Type: -
Identifier Source: org_study_id
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