<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/NCT03774862</url>
  </required_header>
  <id_info>
    <org_study_id>VKVAmericanH</org_study_id>
    <nct_id>NCT03774862</nct_id>
  </id_info>
  <brief_title>Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study</brief_title>
  <official_title>Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>V.K.V. American Hospital, Istanbul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>V.K.V. American Hospital, Istanbul</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medullary carcinoma (MC) is a rare tumor with solid growth pattern without glandular&#xD;
      differentiation and constitute less than 1% of colorectal cancer. Lymph node positivity and&#xD;
      distant organ metastasis were reported to be lower than other poorly differentiated&#xD;
      adenocarcinomas. Therefore, the diagnosis of MC is pathologically important in terms of&#xD;
      follow-up and treatment. MC is commonly localized in the right colon, has a large tumor size,&#xD;
      and is mostly diagnosed in the T4 stage. As MC most likely have defects in DNA MMR, the&#xD;
      correct pathological diagnosis is important for the postoperative treatment and the prognosis&#xD;
      of the patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      427 patients with colorectal cancer who were underwent surgery between January 2011 and&#xD;
      December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414)&#xD;
      in terms of demographic characteristics, pathological data and oncological outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival of medullar colorectal carcinomas</measure>
    <time_frame>7 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Colorectal Medullary Carcinoma</condition>
  <arm_group>
    <arm_group_label>Medullary carcinoma of colorectal cancers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-medullary carcinomas of the colorectal cancers</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        427 patients with colorectal cancer who were underwent surgery between January 2011 and&#xD;
        December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414)&#xD;
        in terms of demographic characteristics, pathological data and oncological outcomes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  colorectal cancer diagnosis, medullary carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>V.K.V. American Hospital, Istanbul</investigator_affiliation>
    <investigator_full_name>Serkan Zenger MD</investigator_full_name>
    <investigator_title>General surgery specialist</investigator_title>
  </responsible_party>
  <keyword>Medullary carcinoma</keyword>
  <keyword>Colorectal cancer</keyword>
  <keyword>Microsatellite instability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Medullary</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</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/NCT03774862
org study id: VKVAmericanH
nct id: NCT03774862
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Medullary carcinoma (MC) is a rare tumor with solid growth pattern without glandular
      differentiation and constitute less than 1% of colorectal cancer. Lymph node positivity and
      distant organ metastasis were reported to be lower than other poorly differentiated
      adenocarcinomas. Therefore, the diagnosis of MC is pathologically important in terms of
      follow-up and treatment. MC is commonly localized in the right colon, has a large tumor size,
      and is mostly diagnosed in the T4 stage. As MC most likely have defects in DNA MMR, the
      correct pathological diagnosis is important for the postoperative treatment and the prognosis
      of the patients.
427 patients with colorectal cancer who were underwent surgery between January 2011 and
      December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414)
      in terms of demographic characteristics, pathological data and oncological outcomes.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival of medullar colorectal carcinomas
time frame: 7 years
arm group label: Medullary carcinoma of colorectal cancers
arm group label: non-medullary carcinomas of the colorectal cancers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: V.K.V. American Hospital, Istanbul
investigator full name: Serkan Zenger MD
investigator title: General surgery specialist
mesh term: Carcinoma
mesh term: Carcinoma, Medullary
mesh term: Thyroid Neoplasms
mesh term: Carcinoma, Neuroendocrine
sharing ipd: No