<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981862</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01085-46</org_study_id>
    <nct_id>NCT02981862</nct_id>
  </id_info>
  <brief_title>CaptHPV : Validation of the Method &quot;CaptHPV&quot; for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas</brief_title>
  <acronym>CaptHPV</acronym>
  <official_title>Monocentric Study of Validation of the Method &quot;CaptHPV&quot; for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current project is based on the assumption that a diagnosis of human papillomavirus&#xD;
      associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical&#xD;
      Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at&#xD;
      any stage of the disease and including surgical treatment for the small tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Actual">June 12, 2018</completion_date>
  <primary_completion_date type="Actual">June 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessement of CaptHPV method</measure>
    <time_frame>1 day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Vulvar Cancer</condition>
  <condition>Anal Cancer</condition>
  <condition>Oropharynx Cancer</condition>
  <condition>Oral Cavity Cancer</condition>
  <condition>Penis Cancer</condition>
  <arm_group>
    <arm_group_label>CaptHPV method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CaptHPV method</intervention_name>
    <description>20 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.&#xD;
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&#xD;
The results of both analyzes will be compared blindly.</description>
    <arm_group_label>CaptHPV method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Patient with cervical cancer, vulvar cancer, anal cancer, oropharynx cancer, oral&#xD;
             cavity cancer or penis cancer&#xD;
&#xD;
          -  Patient naive of any treatment for this pathology&#xD;
&#xD;
          -  Patient capable and willing to follow all procedures of the study in accordance with&#xD;
             the study&#xD;
&#xD;
          -  Ability to provide an informed written consent form&#xD;
&#xD;
          -  Affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already undergone surgical treatment leading to complete removal of&#xD;
             the lesions or who have started treatment with radiotherapy and / or chemotherapy&#xD;
&#xD;
          -  Patient whose health status contraindicates a blood sample of 20 ml,&#xD;
&#xD;
          -  Absence of informed written consent form&#xD;
&#xD;
          -  Pregnant or breast feeding females&#xD;
&#xD;
          -  Patients deprived of liberty or under supervision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SASTRE-GARAU Xavier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie de Lorraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandoeuvre-lès-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Sastre-Garau X, Diop M, Martin F, Dolivet G, Marchal F, Charra-Brunaud C, Peiffert D, Leufflen L, Dembele B, Demange J, Tosti P, Thomas J, Leroux A, Merlin JL, Diop-Ndiaye H, Costa JM, Salleron J, Harle A. A NGS-based Blood Test For the Diagnosis of Invasive HPV-associated Carcinomas with Extensive Viral Genomic Characterization. Clin Cancer Res. 2021 Oct 1;27(19):5307-5316. doi: 10.1158/1078-0432.CCR-21-0293.</citation>
    <PMID>34108183</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HPV infection</keyword>
  <keyword>Blood sample</keyword>
  <keyword>Biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anus Neoplasms</mesh_term>
    <mesh_term>Vulvar Neoplasms</mesh_term>
    <mesh_term>Mouth Neoplasms</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Penile Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981862
org study id: 2016-A01085-46
nct id: NCT02981862
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assessement of CaptHPV method
time frame: 1 day
description: 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.
arm group label: CaptHPV method
arm group type: Experimental
intervention type: Other
intervention name: CaptHPV method
description: 20 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.
arm group label: CaptHPV method
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SASTRE-GARAU Xavier, MD
role: Principal Investigator
affiliation: Institut de Cancérologie de Lorraine
facility: 
country: France
citation: Sastre-Garau X, Diop M, Martin F, Dolivet G, Marchal F, Charra-Brunaud C, Peiffert D, Leufflen L, Dembele B, Demange J, Tosti P, Thomas J, Leroux A, Merlin JL, Diop-Ndiaye H, Costa JM, Salleron J, Harle A. A NGS-based Blood Test For the Diagnosis of Invasive HPV-associated Carcinomas with Extensive Viral Genomic Characterization. Clin Cancer Res. 2021 Oct 1;27(19):5307-5316. doi: 10.1158/1078-0432.CCR-21-0293.
PMID: 34108183
responsible party type: Sponsor
mesh term: Anus Neoplasms
mesh term: Vulvar Neoplasms
mesh term: Mouth Neoplasms
mesh term: Oropharyngeal Neoplasms
mesh term: Penile Neoplasms
sharing ipd: No