<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/NCT04491409</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0130</org_study_id>
    <secondary_id>NCI-2020-04546</secondary_id>
    <secondary_id>2020-0130</secondary_id>
    <nct_id>NCT04491409</nct_id>
  </id_info>
  <brief_title>Perioperative Care in the Cancer Patient -1, ARCA-1 Study</brief_title>
  <official_title>ARCA-1 Study: Perioperative Care in the Cancer Patient -1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <brief_summary>
    <textblock>
      This study investigates the association of blood transfusions given around the time of&#xD;
      surgery (perioperative) with complications after surgery (postoperative), cancer progression,&#xD;
      and mortality after major oncologic non-cardiac surgery. The administration of blood products&#xD;
      is an important clinical therapy to treat life-threatening blood (hematological) disorders&#xD;
      (i.e. anemia, coagulation disorders or thrombocytopenia) in patients with cancer undergoing&#xD;
      major non-cardiac surgery. On the other hand, the unnecessary exposure of those patients to&#xD;
      blood products can be associated with the occurrence of unwanted severe complications and&#xD;
      potentially increase the risk of death. An accurate understanding of the short and long-term&#xD;
      outcomes, the patterns of blood transfusions, and the triggers of blood product&#xD;
      administration may help researchers design and test the safety of perioperative blood&#xD;
      transfusions in patients with cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate if perioperative blood transfusions are associated with 1-year mortality.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the association of blood transfusion with postoperative complications, 30 days&#xD;
      mortality and cancer progression after major oncologic non-cardiac surgery.&#xD;
&#xD;
      II. To gain knowledge on prevalence and patterns of blood product administration worldwide,&#xD;
      the incidence and management of perioperative anemia and the incidence and treatment of&#xD;
      perioperative coagulopathies.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo standard of care treatment and their medical records are reviewed at 30 days&#xD;
      and at 1 year after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>All causes of mortality</measure>
    <time_frame>1 year after major oncologic non-cardiac surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific mortality</measure>
    <time_frame>1 year after major oncologic non-cardiac surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>From the date of surgery to the date of progression or death whichever happened first, assessed at 1 year after major oncologic non-cardiac surgery</time_frame>
    <description>Kaplan-Meier method will be used to estimate the PFS, and the log-rank test will be used to evaluate the difference in PFS between the RBCT group and non-RBCT group. PFS rate at 1 year will be reported. Multivariable Cox proportional hazards models may be used to evaluate the effect of RBCT on PFS with the adjustment of other important covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 days mortality</measure>
    <time_frame>30 days after major oncologic non-cardiac surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of perioperative blood products transfusion</measure>
    <time_frame>During surgery and up to 2 weeks post surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Observational (standard of care, medical chart review)</arm_group_label>
    <description>Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Undergo standard of care</description>
    <arm_group_label>Observational (standard of care, medical chart review)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Chart Review</intervention_name>
    <description>Medical charts reviewed</description>
    <arm_group_label>Observational (standard of care, medical chart review)</arm_group_label>
    <other_name>Chart Review</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient undergoing major cancer surgery with curative intent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient undergoing major cancer surgery with curative intent&#xD;
&#xD;
          -  Planned length of stay 24 hours after surgery or longer&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status (ASA) 1-4&#xD;
&#xD;
          -  Scheduled, non-emergency surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Palliative surgeries for metastatic disease (non-curative intent)&#xD;
&#xD;
          -  Patients undergoing surgery with minimum risk (&lt; 1%) of blood transfusion according to&#xD;
             each center practice (i.e. simple mastectomy, thyroidectomies or wide-local excisions)&#xD;
&#xD;
          -  Patients undergoing surgery under local anesthesia&#xD;
&#xD;
          -  Patients undergoing ambulatory surgery or planned hospital admission of less than 24&#xD;
             hours&#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>Juan P Cata</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juan P. Cata</last_name>
    <phone>713-792-7452</phone>
    <email>jcata@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan P. Cata</last_name>
      <phone>713-792-7452</phone>
      <email>jcata@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Juan P. Cata</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</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>Neoplasms</mesh_term>
  </condition_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/NCT04491409
org study id: 2020-0130
secondary id: NCI-2020-04546
secondary id: 2020-0130
nct id: NCT04491409
lead sponsor: 
collaborator: 
This study investigates the association of blood transfusions given around the time of
      surgery (perioperative) with complications after surgery (postoperative), cancer progression,
      and mortality after major oncologic non-cardiac surgery. The administration of blood products
      is an important clinical therapy to treat life-threatening blood (hematological) disorders
      (i.e. anemia, coagulation disorders or thrombocytopenia) in patients with cancer undergoing
      major non-cardiac surgery. On the other hand, the unnecessary exposure of those patients to
      blood products can be associated with the occurrence of unwanted severe complications and
      potentially increase the risk of death. An accurate understanding of the short and long-term
      outcomes, the patterns of blood transfusions, and the triggers of blood product
      administration may help researchers design and test the safety of perioperative blood
      transfusions in patients with cancer.
PRIMARY OBJECTIVE:

      I. To evaluate if perioperative blood transfusions are associated with 1-year mortality.

      SECONDARY OBJECTIVES:

      I. To evaluate the association of blood transfusion with postoperative complications, 30 days
      mortality and cancer progression after major oncologic non-cardiac surgery.

      II. To gain knowledge on prevalence and patterns of blood product administration worldwide,
      the incidence and management of perioperative anemia and the incidence and treatment of
      perioperative coagulopathies.

      OUTLINE:

      Patients undergo standard of care treatment and their medical records are reviewed at 30 days
      and at 1 year after surgery.
observational model: Cohort
time perspective: Prospective
measure: All causes of mortality
time frame: 1 year after major oncologic non-cardiac surgery
measure: Cancer-specific mortality
time frame: 1 year after major oncologic non-cardiac surgery
measure: Progression free survival (PFS)
time frame: From the date of surgery to the date of progression or death whichever happened first, assessed at 1 year after major oncologic non-cardiac surgery
description: Kaplan-Meier method will be used to estimate the PFS, and the log-rank test will be used to evaluate the difference in PFS between the RBCT group and non-RBCT group. PFS rate at 1 year will be reported. Multivariable Cox proportional hazards models may be used to evaluate the effect of RBCT on PFS with the adjustment of other important covariates.
measure: 30 days mortality
time frame: 30 days after major oncologic non-cardiac surgery
measure: Rate of perioperative blood products transfusion
time frame: During surgery and up to 2 weeks post surgery
arm group label: Observational (standard of care, medical chart review)
description: Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.
intervention type: Other
intervention name: Best Practice
description: Undergo standard of care
arm group label: Observational (standard of care, medical chart review)
other name: standard of care
other name: standard therapy
intervention type: Other
intervention name: Medical Chart Review
description: Medical charts reviewed
arm group label: Observational (standard of care, medical chart review)
other name: Chart Review
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juan P Cata
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Juan P. Cata
phone: 713-792-7452
email: jcata@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: Related Info
responsible party type: Sponsor
mesh term: Neoplasms