<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/NCT02990104</url>
  </required_header>
  <id_info>
    <org_study_id>2016001/PR-GTLA</org_study_id>
    <nct_id>NCT02990104</nct_id>
  </id_info>
  <brief_title>First Report, Five Years Experience of the Acute Leukemia Work Group</brief_title>
  <acronym>PR-GTLA</acronym>
  <official_title>Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mexican Agrupation for Hematology Study</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mexican Agrupation for Hematology Study</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe the incidence, clinic characteristics, biological&#xD;
      and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia&#xD;
      diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with&#xD;
      50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between&#xD;
      500 and 1000 patients it will descriptive statistics of variables. The data collection with&#xD;
      necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and&#xD;
      risk proportional method Cox.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals</measure>
    <time_frame>5 years</time_frame>
    <description>Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals</measure>
    <time_frame>5 years</time_frame>
    <description>Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Acute Leukemia (Category)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Acute Lymphoblastic Leukemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Acute Lymphoblastic Leukemia&#xD;
&#xD;
        Exclusion Criteria none&#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>Dr. Erick Crespo, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regional Hospital High Speciality, Tamaulipas Cd. Victoria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dra. Roberta Demichelis, Doctor</last_name>
    <phone>015554870900</phone>
    <phone_ext>2700</phone_ext>
    <email>robertademichelis@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dra. Karla Espinoza, Doctor</last_name>
    <phone>015556280400</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Mexico Distrito Federal</city>
        <zip>1400</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberta Demichelis, Doctor</last_name>
      <phone>015554870900</phone>
      <phone_ext>2700</phone_ext>
      <email>robertademichelis@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Karla Espinoza, Doctor</last_name>
      <phone>015556280400</phone>
      <phone_ext>60035</phone_ext>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</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>Leukemia</mesh_term>
    <mesh_term>Acute Disease</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/NCT02990104
org study id: 2016001/PR-GTLA
nct id: NCT02990104
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to describe the incidence, clinic characteristics, biological
      and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.
Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia
      diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with
      50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between
      500 and 1000 patients it will descriptive statistics of variables. The data collection with
      necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and
      risk proportional method Cox.
observational model: Case-Only
time perspective: Retrospective
measure: Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals
time frame: 5 years
description: Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals
measure: Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals
time frame: 5 years
description: Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Erick Crespo, Doctor
role: Principal Investigator
affiliation: Regional Hospital High Speciality, Tamaulipas Cd. Victoria
last name: Dra. Roberta Demichelis, Doctor
phone: 015554870900
phone ext: 2700
email: robertademichelis@gmail.com
last name: Dra. Karla Espinoza, Doctor
phone: 015556280400
facility: 
status: Recruiting
contact: 
contact backup: 
country: Mexico
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Acute Disease
sharing ipd: Undecided