HPV Infections, Cancer of the Vulva and Therapeutical Success

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082950
• Other study ID #: HL-15-220
• Status: Completed
• Start date: October 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HPV
• Human Papilloma Virus
• Papilloma
• Papillomavirus Infections

Intervention

Diagnostic Test:
• polymerase chain reaction
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.

Locations

Country	Name	City	State
Germany	Luebeck University, Department for obstetrics and gynecology	Luebeck	Schleswig Holstein

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	EUROIMMUN Medizinische Labordiagnostika AG

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions		15yrs
Secondary	disease free survival among the groups		15yrs