<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/NCT03235648</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.05.162</org_study_id>
    <nct_id>NCT03235648</nct_id>
  </id_info>
  <brief_title>Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer</brief_title>
  <official_title>Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced&#xD;
      ovarian cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is&#xD;
      still debatable , correlation of radiological finding with pathological findings after&#xD;
      reaction of radiological positive lymph nodes and its impact in diseases free survival and&#xD;
      over all survival&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of CPN retrieved/pathological nodes</measure>
    <time_frame>up to 3 years</time_frame>
    <description>correlation of radiological active lymph nodes with pathological findings</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>up to 2 years following the end of study</time_frame>
    <description>2 years progression without disease recurrence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 2 years following the end of study</time_frame>
    <description>2 years survivals of the patients</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>cardiophrenic nodes excision in ovarian cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiophrenic lymph nodes resection</intervention_name>
    <description>surgical resection</description>
    <arm_group_label>cardiophrenic nodes excision in ovarian cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Ovarian cancer patient (FIGO stage III-IV)&#xD;
&#xD;
          -  Preoperative CT showing CPLN with short axis diameter &gt; 5mm.&#xD;
&#xD;
          -  Anathestically fit patient (ASA score I or II).&#xD;
&#xD;
          -  Accepted pulmonary function test.&#xD;
&#xD;
          -  Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1&#xD;
             cm )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anathestically unfit patient&#xD;
&#xD;
          -  Unresectable disease&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  No detected CPLN by preoperative radiology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Basel R. Abdelfattah, MD, MRCS</last_name>
    <phone>01001974340</phone>
    <phone_ext>+2</phone_ext>
    <email>dr.basel@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oncology center, Mansoura University</name>
      <address>
        <city>Cairo</city>
        <state>Dakhlia</state>
        <zip>35116</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Basel R. Abdelfattah, MD,MRCS</last_name>
      <phone>01001974340</phone>
      <phone_ext>+2</phone_ext>
      <email>dr.basel@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 2, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Basel Refky, MD</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT03235648
org study id: R/17.05.162
nct id: NCT03235648
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced
      ovarian cancer
The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is
      still debatable , correlation of radiological finding with pathological findings after
      reaction of radiological positive lymph nodes and its impact in diseases free survival and
      over all survival
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of CPN retrieved/pathological nodes
time frame: up to 3 years
description: correlation of radiological active lymph nodes with pathological findings
measure: Progression free survival
time frame: up to 2 years following the end of study
description: 2 years progression without disease recurrence
measure: Overall survival
time frame: up to 2 years following the end of study
description: 2 years survivals of the patients
arm group label: cardiophrenic nodes excision in ovarian cancer
arm group type: Experimental
description: We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes
intervention type: Procedure
intervention name: cardiophrenic lymph nodes resection
description: surgical resection
arm group label: cardiophrenic nodes excision in ovarian cancer
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Basel R. Abdelfattah, MD, MRCS
phone: 01001974340
phone ext: +2
email: dr.basel@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Basel Refky, MD
investigator title: Doctor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No