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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Assessement of CaptHPV method


Condition

Cervical Cancer

Intervention

CaptHPV method

Study Arms / Comparison Groups

 CaptHPV method
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

December 19, 2016

Completion Date

June 12, 2018

Primary Completion Date

June 12, 2018

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

SASTRE-GARAU Xavier, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02981862

Organization ID

2016-A01085-46


Responsible Party

Sponsor

Study Sponsor

Institut de Cancérologie de Lorraine


Study Sponsor

SASTRE-GARAU Xavier, MD, Principal Investigator, Institut de Cancérologie de Lorraine


Verification Date

June 2019