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

This study is currently recruiting participants.
Verified October 2017 by Institut de Cancérologie de Lorraine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981862
First Posted: December 5, 2016
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine
  Purpose
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 or Oropharynx Cancer at any stage of the disease and including surgical treatment for the small tumors.

Condition Intervention
Cervical Cancer Vulvar Cancer Anal Cancer Oropharynx Cancer Other: CaptHPV method

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.

Resource links provided by NLM:


Further study details as provided by Institut de Cancérologie de Lorraine:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Actual Study Start Date: December 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Patient with cervical cancer or vulvar cancer or anal cancer or oropharynx cancer
  • Patient naive of any treatment for this pathology
  • Patient capable and willing to follow all procedures of the study in accordance with the stydy
  • 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 10 ml,
  • Absence of informed written consent form
  • Pregnant or breast feeding females
  • Patients deprived of liberty or under supervision
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: MERLIN Jean Louis + 33 3 83 59 83 07 jl.merlin@nancy.unicancer.fr
Contact: FERNANDES Laurinda + 33 3 83 59 84 87 l.fernandes@nancy.unicancer.fr

Locations
France
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-lès-Nancy, France, 54519
Contact: SASTRE-GARAU Xavier, MD    + 33 3 83 59 84 83    x.sastregarau@nancy.unicancer.fr   
Contact: CHARRA-BRUNAUD Claire, MD    + 33 3 83 59 84 87    c.brunaud@nancy.unicancer.fr   
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
Principal Investigator: SASTRE-GARAU Xavier, MD Institut de Cancérologie de Lorraine
  More Information

Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02981862     History of Changes
Other Study ID Numbers: 2016-A01085-46
First Submitted: November 30, 2016
First Posted: December 5, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut de Cancérologie de Lorraine:
HPV infection
Blood sample
Biopsy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Anus Neoplasms
Vulvar Neoplasms
Oropharyngeal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Vulvar Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases