<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/NCT03803670</url>
  </required_header>
  <id_info>
    <org_study_id>RS176/17</org_study_id>
    <nct_id>NCT03803670</nct_id>
  </id_info>
  <brief_title>Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rome Tor Vergata</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of&#xD;
      patients affected by acute lymphoblastic leukemia. The investigators have previously reported&#xD;
      that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the&#xD;
      presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in&#xD;
      samples with low cell counts. In the framework of the national Campus ALL program aimed at&#xD;
      improving the management of adult ALL patients in the context of the GIMEMA protocols, in the&#xD;
      present study the investigators retrospectively evaluated the incidence of occult CNS&#xD;
      positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13&#xD;
      centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Demographic and of laboratory data of 241 adult patients with ALL were retrospectively&#xD;
      recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid&#xD;
      sample was examined by CC and FCM. The investigators identified patients with the only FCM&#xD;
      positivity and the investigators correlated this condition with clinical and of laboratory&#xD;
      data and with clinical outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1, 2007</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>impact of occult CNS disease</measure>
    <time_frame>10 years</time_frame>
    <description>relapse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>impact of occult CNS disease on outcome</measure>
    <time_frame>10 years</time_frame>
    <description>overall survival</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">241</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>acute lymphoblastic leukemia patients</arm_group_label>
    <description>We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>evaluation of cerebrospinal fluid of ALL</intervention_name>
    <description>We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry</description>
    <arm_group_label>acute lymphoblastic leukemia patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients affected by ALL underwent to diagnostic lumbar puncture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ALL at onset&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ALL relapsed or refractory&#xD;
&#xD;
          -  Age &lt;18 years&#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>Maria Ilaria Del Principe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Tor Vergata of Rome</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
    <investigator_full_name>Maria Ilaria Del Principe</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>acute lymphoblastic leukemia</keyword>
  <keyword>flow cytometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</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/NCT03803670
org study id: RS176/17
nct id: NCT03803670
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of
      patients affected by acute lymphoblastic leukemia. The investigators have previously reported
      that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the
      presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in
      samples with low cell counts. In the framework of the national Campus ALL program aimed at
      improving the management of adult ALL patients in the context of the GIMEMA protocols, in the
      present study the investigators retrospectively evaluated the incidence of occult CNS
      positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13
      centers.
Demographic and of laboratory data of 241 adult patients with ALL were retrospectively
      recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid
      sample was examined by CC and FCM. The investigators identified patients with the only FCM
      positivity and the investigators correlated this condition with clinical and of laboratory
      data and with clinical outcome.
observational model: Case-Only
time perspective: Retrospective
measure: impact of occult CNS disease
time frame: 10 years
description: relapse rate
measure: impact of occult CNS disease on outcome
time frame: 10 years
description: overall survival
arm group label: acute lymphoblastic leukemia patients
description: We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement.
intervention type: Diagnostic Test
intervention name: evaluation of cerebrospinal fluid of ALL
description: We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry
arm group label: acute lymphoblastic leukemia patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maria Ilaria Del Principe, MD
role: Principal Investigator
affiliation: University Tor Vergata of Rome
responsible party type: Principal Investigator
investigator affiliation: University of Rome Tor Vergata
investigator full name: Maria Ilaria Del Principe
investigator title: PI
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
sharing ipd: No