HPV Infections, Cancer of the Vulva and Therapeutical Success

NCT03082950 | Completed

• 1 other identifier: HL-15-220
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV; Human Papilloma Virus

Keywords

hpv prevalence; recurrence rate; survival

Outcome Measures

Primary Outcomes (1)

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

  15yrs

Secondary Outcomes (1)

• disease free survival among the groups

  15yrs

Study Arms (2)

1

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

Diagnostic Test: polymerase chain reaction

2

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

Diagnostic Test: polymerase chain reaction

Interventions

polymerase chain reaction DIAGNOSTIC_TEST

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

Also known as: EUROARRAY

1; 2

Eligibility Criteria

• Gender Eligibility Details: female the illness only affiliates females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• pts. who suffer from vulvar cancer and their preinvasive lesions
• positive informed consent
• complete set of data
• Treatment in luebeck university

You may not qualify if:

• opposite of above

Sponsors & Collaborators

• University of Luebeck: lead
• EUROIMMUN Medizinische Labordiagnostika AG: collaborator

Study Sites (1)

Luebeck University, Department for obstetrics and gynecology

Lübeck, Schleswig-Holstein, D-23538, Germany

Location

Related Publications (3)

• 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.

  PMID: 19550210 BACKGROUND

• 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.

  PMID: 23710698 BACKGROUND

• 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.

  PMID: 21289941 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples are analyzed according to their hpv status

Study Officials

• Daniel Beyer, MD

  Westpfalz-Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Luebeck

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 17, 2017
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

DE (1)