<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/NCT01716065</url>
  </required_header>
  <id_info>
    <org_study_id>355841-17</org_study_id>
    <nct_id>NCT01716065</nct_id>
  </id_info>
  <brief_title>Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)</brief_title>
  <acronym>CTC</acronym>
  <official_title>Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Defense and Veterans Center for Integrative Pain Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Defense and Veterans Center for Integrative Pain Management</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine whether the type of anesthesia during breast cancer&#xD;
      surgery has any impact on the way a patient's immune system functions for a brief period&#xD;
      after surgery. If the investigators find that one type of anesthesia versus the other is more&#xD;
      beneficial to a patient's immune system, then the investigators may use this information to&#xD;
      design a larger study to exam the effect of anesthesia better.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two different types of anesthesia that the investigators can use for subjects&#xD;
      undergoing breast surgery. The first type is called &quot;general anesthesia&quot; (GA) which is when a&#xD;
      person &quot;goes to sleep&quot; with a breathing tube and then receives intravenous (IV) pain medicine&#xD;
      during and after surgery to minimize surgical pain. The other type of anesthesia is called&#xD;
      &quot;regional anesthesia&quot; (RA), or &quot;nerve blocks&quot; which numb up the nerves that supply the breast&#xD;
      area. By doing this type of anesthesia, subjects often don't go &quot;to sleep&quot; with a breathing&#xD;
      tube, instead, they get heavy IV sedation and take a &quot;deep nap&quot; during the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <primary_completion_date type="Actual">May 2013</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>Circulating Tumor Cells</measure>
    <time_frame>5 days</time_frame>
    <description>blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of cytokines</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>breast cancer antibodies</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dendritic Cells</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T and B lymphocytes</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Natural Killer Cells (NK cells)</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Breast Cancer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples collected for CTC analysis (2 tubes of 8ml of blood) will be drawn at 4 time points:&#xD;
      pre-operative (at least 24 hours before surgery), immediate prior to surgery, 12-24 hours&#xD;
      post-operative, and 5-7 days post-operative.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll female and male military health care beneficiaries between the ages 18-85&#xD;
        years old presenting with the diagnosis of primary non-metastatic breast cancer, American&#xD;
        Joint Committee on Cancer (AJCC) Stages I, II or III, undergoing surgery with curative&#xD;
        intent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects should be over 18 years of age and capable of providing&#xD;
             informed consent indicating awareness of the investigational nature of this trial, in&#xD;
             keeping with institutional policy&#xD;
&#xD;
          -  Written informed consent must be obtained from each subject prior to entering the&#xD;
             study&#xD;
&#xD;
          -  Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo&#xD;
             either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary&#xD;
             dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary lymph&#xD;
             node dissection&#xD;
&#xD;
          -  Able to stay overnight in the hospital post surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any subject younger than 18 years or older than 85 years of age&#xD;
&#xD;
          -  History of previous breast surgery (aside from biopsy), planned breast conserving&#xD;
             operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)&#xD;
&#xD;
          -  American Society of Anesthesia (ASA) classification of 4 or greater, or any&#xD;
             contraindication to having regional anesthesia&#xD;
&#xD;
          -  Any subjects who receives an intraoperative or postoperative blood transfusion during&#xD;
             the period of venous blood sampling&#xD;
&#xD;
          -  Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing (urine&#xD;
             HCG) or by history (tubal ligation, hysterectomy, or menopause) is required prior to&#xD;
             inclusion in the study&#xD;
&#xD;
          -  Subjects with active infectious process at the site of proposed paravertebral&#xD;
             injection&#xD;
&#xD;
          -  Subjects with significant allergy to local anesthetics&#xD;
&#xD;
          -  Subjects who convert from RA to GA during surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>April 29, 2014</last_update_submitted>
  <last_update_submitted_qc>April 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anesthesia, Circulating tumor cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</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/NCT01716065
org study id: 355841-17
nct id: NCT01716065
lead sponsor: 
has dmc: No
The purpose of the study is to determine whether the type of anesthesia during breast cancer
      surgery has any impact on the way a patient's immune system functions for a brief period
      after surgery. If the investigators find that one type of anesthesia versus the other is more
      beneficial to a patient's immune system, then the investigators may use this information to
      design a larger study to exam the effect of anesthesia better.
There are two different types of anesthesia that the investigators can use for subjects
      undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when a
      person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine
      during and after surgery to minimize surgical pain. The other type of anesthesia is called
      "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply the breast
      area. By doing this type of anesthesia, subjects often don't go "to sleep" with a breathing
      tube, instead, they get heavy IV sedation and take a "deep nap" during the surgery.
observational model: Cohort
time perspective: Prospective
measure: Circulating Tumor Cells
time frame: 5 days
description: blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment
measure: Levels of cytokines
time frame: 5 days
measure: breast cancer antibodies
time frame: 5 days
measure: Dendritic Cells
time frame: 5 days
measure: T and B lymphocytes
time frame: 5 days
measure: Natural Killer Cells (NK cells)
time frame: 5 days
Samples collected for CTC analysis (2 tubes of 8ml of blood) will be drawn at 4 time points:
      pre-operative (at least 24 hours before surgery), immediate prior to surgery, 12-24 hours
      post-operative, and 5-7 days post-operative.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplastic Cells, Circulating