CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas (CaptHPV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02981862|
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Vulvar Cancer Anal Cancer Oropharynx Cancer||Other: CaptHPV method||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.|
|Actual Study Start Date :||December 19, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: CaptHPV method||
Other: CaptHPV method
10 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981862
|Contact: MERLIN Jean Louis||+ 33 3 83 59 83 firstname.lastname@example.org|
|Contact: FERNANDES Laurinda||+ 33 3 83 59 84 email@example.com|
|Institut de Cancérologie de Lorraine||Recruiting|
|Vandoeuvre-lès-Nancy, France, 54519|
|Contact: SASTRE-GARAU Xavier, MD + 33 3 83 59 84 83 firstname.lastname@example.org|
|Contact: CHARRA-BRUNAUD Claire, MD + 33 3 83 59 84 87 email@example.com|
|Principal Investigator:||SASTRE-GARAU Xavier, MD||Institut de Cancérologie de Lorraine|