CaptHPV : Validation of the Method CaptHPV for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer, Penis Cancer

Intervention / Treatment
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* Other: CaptHPV method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CaptHPV method<br> | Other: CaptHPV method<br>* 20 ml of blood sample will be made before the beginning of all treatment. This blood sample will be sent to the CERBA Laboratory for analysis. In parallel, a standard anatomopathological and virological analysis will be carried out from a biopsy or from a tumor sample by the Tumor Biology Unit at Lorraine Institute of Oncology The results of both analyzes will be compared blindly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessement of CaptHPV method | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV infection, Blood sample, Biopsy