<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/NCT02254941</url>
  </required_header>
  <id_info>
    <org_study_id>GEMCAD 1401</org_study_id>
    <nct_id>NCT02254941</nct_id>
  </id_info>
  <brief_title>Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer</brief_title>
  <official_title>Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol Multidisciplinario del Cancer Digestivo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Espanol Multidisciplinario del Cancer Digestivo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate, in terms of overall survival, the benefit of&#xD;
      monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a&#xD;
      deferred basis after progression to treatment with chemotherapy alone. Initially expected&#xD;
      target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients,&#xD;
      because the size was sufficient to evaluate the superiority of the use of monoclonal&#xD;
      antibodies the start time of the diagnosis against deferred use, with HR of 0.8, power of 90%&#xD;
      and an alpha of 0.05. Finally in July 2018, recruitment was completed with a total of 1104&#xD;
      patients enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Overall survival</measure>
    <time_frame>From July 2018 (LPI), 24 months</time_frame>
    <description>From date of inclusion until the date of death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validate prognostic score GEMCAD</measure>
    <time_frame>From August 2014, up to 36 months</time_frame>
    <description>The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores.&#xD;
GEMCAD score: patients are classified as stage 1 if LiM are considered resectable (&lt;4 nodules and &lt;5 cm diameter) or potentially resectable (&gt;4 and &lt;10 nodules or &gt;5 cm diameter), PS 0-1 and LDH &lt; 1.5 ULN; stage 2 if LiM are not resectable or with extrahepatic spread, PS 0-1 and LDH &lt; 1.5 ULN; stage3 if PS 2 or LDH &gt; 1.5 ULN.&#xD;
This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare GERCOR and Köhne classification with GEMCAD classification</measure>
    <time_frame>From August 2014, up to 36 months</time_frame>
    <description>The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores.&#xD;
This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate Sadananda cellular phenotype classification</measure>
    <time_frame>From August 2014, up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study other variables to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy</measure>
    <time_frame>From August 2014, up to 36 months</time_frame>
    <description>Study whether there are demographic variables, analytical or related tumor and its extension to allow us to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1104</enrollment>
  <condition>Metastatic Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Active comparator: Chemotherapy</arm_group_label>
    <description>Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Chemotherapy plus mAb</arm_group_label>
    <description>Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Metastatic colon cancer, first line treatment with conventional chemotherapy</description>
    <arm_group_label>Active comparator: Chemotherapy</arm_group_label>
    <other_name>Standard Chemotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Chemotherapy plus monoclonal antibody</intervention_name>
    <description>Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody</description>
    <arm_group_label>Experimental: Chemotherapy plus mAb</arm_group_label>
    <other_name>Standard CHemotherapy plus monoclonal antibody</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Colon biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Metastatic colorectal cancer. Adenocarcinoma. First line treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with metastatic colorectal cancer with biopsy positive for&#xD;
             adenocarcinoma.&#xD;
&#xD;
          -  ECOG PS0-2.&#xD;
&#xD;
          -  Who have not received prior chemotherapy treatment for metastatic disease.&#xD;
&#xD;
          -  Measurable or evaluable disease.&#xD;
&#xD;
          -  No previous surgery for metastatic disease. Surgery for metastasis allowed after&#xD;
             inclusion in the study aftercare at the discretion of investigadors.&#xD;
&#xD;
          -  Chemotherapy treatment with doublets (CAPOX, FOLFOX, FOLFIRI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients older than 70 years with frailty criteria.&#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>Joan Maurel, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Virgen de los Lirios</name>
      <address>
        <city>Alcoy</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario del Vinalopó</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elda</name>
      <address>
        <city>Elda</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Torrevieja</name>
      <address>
        <city>Torrevieja</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragon</state>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Granollers</name>
      <address>
        <city>Granollers</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporació Sanitària Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>Sant Cugat del Vallès</city>
        <state>Barcelona</state>
        <zip>08190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Terrasa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Vic</name>
      <address>
        <city>Vic</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Puerto de Plasencia</name>
      <address>
        <city>Plasencia</city>
        <state>Cáceres</state>
        <zip>10600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donostia</name>
      <address>
        <city>San Sebastián</city>
        <state>Guipúzcoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico de Galicia</name>
      <address>
        <city>A Coruña</city>
        <state>La Coruña</state>
        <zip>15009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria Doctor Negrín</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Las Palmas</state>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro de Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma</city>
        <state>Malllorca</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Costa del Sol</name>
      <address>
        <city>Marbella</city>
        <state>Málaga</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Lluis Alcanyis de Xátiva</name>
      <address>
        <city>Xàtiva</city>
        <state>Valencia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Obispo Polanco</name>
      <address>
        <city>Teruel</city>
        <state>Zaragoza</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Cristina de Badajoz</name>
      <address>
        <city>Badajoz</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Mèdic Teknon</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosptial de l'Esperit Sant de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08923</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Plató</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Sagrat Cor</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospitalario Provincial de Castellón</name>
      <address>
        <city>Castelló</city>
        <zip>12002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Ciudad Real</name>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcantara Cáceres</name>
      <address>
        <city>Cáceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univeritari Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova de Lleida</name>
      <address>
        <city>Lleida</city>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Althaia</name>
      <address>
        <city>Manresa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Ourense</name>
      <address>
        <city>Ourense</city>
        <zip>32005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Llàtzer</name>
      <address>
        <city>Palma de mallorca</city>
        <zip>08198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial de Pontevedra</name>
      <address>
        <city>Pontevedra</city>
        <zip>36002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sagunto</name>
      <address>
        <city>Sagunto</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Doctor Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico de La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Vigo</name>
      <address>
        <city>Vigo</city>
        <zip>36036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Colon Cancer</keyword>
  <keyword>Monoclonal antibodies</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>First line</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02254941
org study id: GEMCAD 1401
nct id: NCT02254941
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate, in terms of overall survival, the benefit of
      monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a
      deferred basis after progression to treatment with chemotherapy alone. Initially expected
      target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients,
      because the size was sufficient to evaluate the superiority of the use of monoclonal
      antibodies the start time of the diagnosis against deferred use, with HR of 0.8, power of 90%
      and an alpha of 0.05. Finally in July 2018, recruitment was completed with a total of 1104
      patients enrolled.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: From July 2018 (LPI), 24 months
description: From date of inclusion until the date of death from any cause.
measure: Validate prognostic score GEMCAD
time frame: From August 2014, up to 36 months
description: The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores.
GEMCAD score: patients are classified as stage 1 if LiM are considered resectable (<4 nodules and <5 cm diameter) or potentially resectable (>4 and <10 nodules or >5 cm diameter), PS 0-1 and LDH < 1.5 ULN; stage 2 if LiM are not resectable or with extrahepatic spread, PS 0-1 and LDH < 1.5 ULN; stage3 if PS 2 or LDH > 1.5 ULN.
This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).
measure: To compare GERCOR and Köhne classification with GEMCAD classification
time frame: From August 2014, up to 36 months
description: The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores.
This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).
measure: Evaluate Sadananda cellular phenotype classification
time frame: From August 2014, up to 36 months
measure: Study other variables to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy
time frame: From August 2014, up to 36 months
description: Study whether there are demographic variables, analytical or related tumor and its extension to allow us to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy
arm group label: Active comparator: Chemotherapy
description: Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
arm group label: Experimental: Chemotherapy plus mAb
description: Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
intervention type: Drug
intervention name: Chemotherapy
description: Metastatic colon cancer, first line treatment with conventional chemotherapy
arm group label: Active comparator: Chemotherapy
other name: Standard Chemotherapy
intervention type: Biological
intervention name: Chemotherapy plus monoclonal antibody
description: Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody
arm group label: Experimental: Chemotherapy plus mAb
other name: Standard CHemotherapy plus monoclonal antibody
Colon biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joan Maurel, MD PhD
role: Study Chair
affiliation: Hospital Clinic of Barcelona
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country: Spain
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Antineoplastic Agents, Immunological
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal