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