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

Not Applicable

Completed

• Conditions: Oropharynx Cancer; Vulvar Cancer; Oral Cavity Cancer; Penis Cancer; Anal Cancer; Cervical Cancer
• Interventions: Other: CaptHPV method

• Registration Number: NCT02981862
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Study Start: 2016-12-19
• Primary Completion: 2018-06-12
• Study Completion: 2018-06-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CaptHPV method	CaptHPV method	-

Primary Outcome Measures

Name	Time	Method
Assessement of CaptHPV method	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.

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-lès-Nancy, France