Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.

Institut de Cancérologie de Lorraine1 site in 1 country100 target enrollmentDecember 19, 2016

ConditionsCervical Cancer Vulvar Cancer Anal Cancer Oropharynx Cancer Oral Cavity Cancer Penis Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Institut de Cancérologie de Lorraine
Enrollment: 100
Locations: 1
Primary Endpoint: Assessement of CaptHPV method
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The current project is based on the assumption that a diagnosis of human papillomavirus associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at any stage of the disease and including surgical treatment for the small tumors.

Registry

clinicaltrials.gov

Start Date

December 19, 2016

End Date

June 12, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institut de Cancérologie de Lorraine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \>18 years
•Patient with cervical cancer, vulvar cancer, anal cancer, oropharynx cancer, oral cavity cancer or penis cancer
•Patient naive of any treatment for this pathology
•Patient capable and willing to follow all procedures of the study in accordance with the study
•Ability to provide an informed written consent form
•Affiliation to a social security system

Exclusion Criteria

•Patients who have already undergone surgical treatment leading to complete removal of the lesions or who have started treatment with radiotherapy and / or chemotherapy
•Patient whose health status contraindicates a blood sample of 20 ml,
•Absence of informed written consent form
•Pregnant or breast feeding females
•Patients deprived of liberty or under supervision

Outcomes

Primary Outcomes

Assessement of CaptHPV method

Time Frame: 1 day

The diagnostic value of the serum marker provided by the method CaptHPV will be assessed in sensitivity and specificity to results of histological and virological analyzes of a sample tumor.