HPV Infections, Cancer of the Vulva and Therapeutical Success

NCT ID: NCT03082950

Last Updated: 2018-05-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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HPV Human Papilloma Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions

polymerase chain reaction

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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EUROARRAY

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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EUROIMMUN Medizinische Labordiagnostika AG

UNKNOWN

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Daniel Alexander Beyer

University of Luebeck

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Germany

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.

Reference Type BACKGROUND
PMID: 19550210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23710698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21289941 (View on PubMed)

Other Identifiers

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HL-15-220

Identifier Type: -

Identifier Source: org_study_id

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