<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/NCT03293433</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/15/7818</org_study_id>
    <nct_id>NCT03293433</nct_id>
  </id_info>
  <brief_title>Quantification of microRNAs in Diagnosis of Pulmonary Nodules</brief_title>
  <acronym>miR-Nod</acronym>
  <official_title>Quantification of microRNAs in Diagnosis of Pulmonary Nodules: Reproducibility Analysis of Intra- and Inter-observer and Inter-laboratory: Project miR-Nod</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to&#xD;
      improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to&#xD;
      late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or&#xD;
      earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed,&#xD;
      supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery&#xD;
      in 80% of patients. Nevertheless, there are many differential diagnoses and access to these&#xD;
      lesions is often difficult and risky. In this context, the management of pulmonary nodules,&#xD;
      which can be either benign lesions or beginners cancers, is a real challenge for&#xD;
      pulmonologists and thoracic oncologists every day: it is important not to disregard a&#xD;
      potentially operable nodule and avoiding offer patients invasive procedures for benign&#xD;
      nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to&#xD;
      determine if suspicious nodules are benign or not. In the large National Lung Screening&#xD;
      Trial, 28% of the procedures were associated with complications (including 11% classified&#xD;
      severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine&#xD;
      treatment decisions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction</measure>
    <time_frame>Through the completion of study (18 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure the inter-observer reproducibility as assessed by quantification of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction</measure>
    <time_frame>Through the completion of study (18 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the inter-laboratory reproducibility as assessed by rate of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction</measure>
    <time_frame>Through the completion of study (18 months)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>Pulmonary Cancer</condition>
  <arm_group>
    <arm_group_label>Patient with lung cancer</arm_group_label>
    <description>Patient with pulmonary nodule showed in scanner (defined as a rounded picture higher than 5 mm and less than 30 mm in the lung parenchyma) presenting at one of the 3 participant services and meeting the inclusion criteria and exclusion. A blood punction will be performed in order to extract micro RNA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood punction</intervention_name>
    <description>1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of micro RNA.</description>
    <arm_group_label>Patient with lung cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Total blood punction with micro RNA exctraction&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with pulmonary nodule showed in scanner (defined as a rounded picture higher than 5&#xD;
        mm and less than 30 mm in the lung parenchyma) presenting at one of the 3 participant&#xD;
        services and meeting the inclusion criteria and exclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected abnormal chest X-ray image of malignancy defined by one&#xD;
             solitary pulmonary nodule (NPS) NPS or 2 if operable, higher than 5 mm and less to 30&#xD;
             mm, without histological evidence.&#xD;
&#xD;
          -  Affiliation to social security.&#xD;
&#xD;
          -  Signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nodule not accessible to curative local therapy (surgery, thermoablation,&#xD;
             radiotherapy).&#xD;
&#xD;
          -  Patients in whom resection for diagnostic purposes this emergency such as one of these&#xD;
             characters can not be delayed (these patients are not likely to belong to the people&#xD;
             that can take a dosage of clinical interest miRNAs because the characteristics&#xD;
             radiographic their nodule only tell them a high probability of lung cancer)&#xD;
&#xD;
          -  History of an unhealed cancer&#xD;
&#xD;
          -  Patients benefiting from a system of legal protection&#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>GUIBERT NICOLAS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of la Réunion</name>
      <address>
        <city>La Réunion</city>
        <zip>97400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 22, 2016</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Pulmonary Nodules</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293433
org study id: RC31/15/7818
nct id: NCT03293433
lead sponsor: 
has dmc: No
One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to
      improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to
      late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or
      earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed,
      supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery
      in 80% of patients. Nevertheless, there are many differential diagnoses and access to these
      lesions is often difficult and risky. In this context, the management of pulmonary nodules,
      which can be either benign lesions or beginners cancers, is a real challenge for
      pulmonologists and thoracic oncologists every day: it is important not to disregard a
      potentially operable nodule and avoiding offer patients invasive procedures for benign
      nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to
      determine if suspicious nodules are benign or not. In the large National Lung Screening
      Trial, 28% of the procedures were associated with complications (including 11% classified
      severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine
      treatment decisions.
observational model: Cohort
time perspective: Prospective
measure: 34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction
time frame: Through the completion of study (18 months)
measure: Measure the inter-observer reproducibility as assessed by quantification of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction
time frame: Through the completion of study (18 months)
measure: Measure the inter-laboratory reproducibility as assessed by rate of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction
time frame: Through the completion of study (18 months)
arm group label: Patient with lung cancer
description: Patient with pulmonary nodule showed in scanner (defined as a rounded picture higher than 5 mm and less than 30 mm in the lung parenchyma) presenting at one of the 3 participant services and meeting the inclusion criteria and exclusion. A blood punction will be performed in order to extract micro RNA.
intervention type: Other
intervention name: Blood punction
description: 1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of micro RNA.
arm group label: Patient with lung cancer
Total blood punction with micro RNA exctraction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GUIBERT NICOLAS, MD
role: Principal Investigator
affiliation: University Hospital of Toulouse
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Pulmonary Nodules
mesh term: Lung Neoplasms
sharing ipd: Undecided