<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/NCT02978131</url>
  </required_header>
  <id_info>
    <org_study_id>OBS-032</org_study_id>
    <nct_id>NCT02978131</nct_id>
  </id_info>
  <brief_title>Histopathological Techniques and PCR on Tissues Included in Paraffin for the Diagnosis of Tuberculosis</brief_title>
  <official_title>Evaluation of the Sensitivity of Histopathological Techniques and Molecular Biology (PCR) on Tissues Fixed in Paraformaldehyde and Included in Paraffin for the Diagnosis of Tuberculosis in Current Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world&#xD;
      population is infected with Mycobacterium tuberculosis. There is an increase in the number of&#xD;
      cases of classic tuberculosis in developing countries, even if number of cases are declining&#xD;
      in developed countries. However, in developed countries this decrease is counterbalanced by&#xD;
      the emergence of multidrug resistant (MDR) strains of the bacteria.&#xD;
&#xD;
      There are also latent forms (1/3 of the world population) of the infection that can be&#xD;
      reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and&#xD;
      9 million new cases are identified, including about 500,000 cases of MDR TB.&#xD;
&#xD;
      The spread of this disease as well as the increasing number of cases of MDR tuberculosis,&#xD;
      reinforce the need for research and development of strategies of diagnosis and management of&#xD;
      this affection.&#xD;
&#xD;
      Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at&#xD;
      least three weeks to be performed. The objective of this study is to evaluate the sensitivity&#xD;
      and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed&#xD;
      and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice,&#xD;
      in order to administrate an efficient treatment as soon as possible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of positive TB cases with different techniques</measure>
    <time_frame>at inclusion</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Diagnostic Techniques and Procedures</condition>
  <condition>Sensitivity and Specificity</condition>
  <condition>Polymerase Chain Reaction</condition>
  <condition>Immunohistochemistry</condition>
  <condition>Histochemistry</condition>
  <arm_group>
    <arm_group_label>Patients with a clinical diagnosis of TB</arm_group_label>
    <description>Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Histopathological study</intervention_name>
    <arm_group_label>Patients with a clinical diagnosis of TB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Molecular study (Polymerase chain reaction)</intervention_name>
    <arm_group_label>Patients with a clinical diagnosis of TB</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Pulmonary and extrapulmonary, paraformaldehyde fixed and paraffin embedded tissues&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive TB patients&#xD;
&#xD;
          -  Patients who performed biopsy before inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anti-tuberculosis drugs administered before biopsy&#xD;
&#xD;
          -  Patients who refuse to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colette Creusy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TUBERCULOSIS</keyword>
  <keyword>Sensitivity and Specificity</keyword>
  <keyword>Polymerase Chain Reaction</keyword>
  <keyword>Immunohistochemistry</keyword>
  <keyword>Histochemistry</keyword>
  <keyword>Paraformaldehyde and paraffin embedded tissues</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT02978131
org study id: OBS-032
nct id: NCT02978131
lead sponsor: 
has dmc: No
Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world
      population is infected with Mycobacterium tuberculosis. There is an increase in the number of
      cases of classic tuberculosis in developing countries, even if number of cases are declining
      in developed countries. However, in developed countries this decrease is counterbalanced by
      the emergence of multidrug resistant (MDR) strains of the bacteria.

      There are also latent forms (1/3 of the world population) of the infection that can be
      reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and
      9 million new cases are identified, including about 500,000 cases of MDR TB.

      The spread of this disease as well as the increasing number of cases of MDR tuberculosis,
      reinforce the need for research and development of strategies of diagnosis and management of
      this affection.

      Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at
      least three weeks to be performed. The objective of this study is to evaluate the sensitivity
      and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed
      and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice,
      in order to administrate an efficient treatment as soon as possible.
observational model: Case-Only
time perspective: Retrospective
measure: Number of positive TB cases with different techniques
time frame: at inclusion
arm group label: Patients with a clinical diagnosis of TB
description: Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples
intervention type: Other
intervention name: Histopathological study
arm group label: Patients with a clinical diagnosis of TB
intervention type: Other
intervention name: Molecular study (Polymerase chain reaction)
arm group label: Patients with a clinical diagnosis of TB
Pulmonary and extrapulmonary, paraformaldehyde fixed and paraffin embedded tissues
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Colette Creusy, MD
role: Principal Investigator
affiliation: GHICL
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Hypersensitivity
sharing ipd: No