<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180720040533N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Diagnosis of  hidden peritoneal metastases in gastric cancers</public_title>
      <acronym></acronym>
      <scientific_title>Diagnosing the prevalence of hidden peritoneal metastases of Gastric  cancers by laparoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64352</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic.</study_design>
      <phase>2</phase>
      <hc_freetext>Gastric cancer.</hc_freetext>
      <i_freetext>Intervention group: At the beginning of the laparoscopy, the entire abdominal area, including the stomach, peritoneum, omentum, pelvis, and liver, is examined with a 30-degree camera, and if there is free fluid in the abdomen, the fluid will be sampled.In the absence of free fluid in the abdomen, Serous viscera in the abdomen and stomach are lavaged with 100 cc of normal saline and then the lavage fluid is aspirated and sent for cytological examination.Then all the peritoneum is examined and if there is any lesion suspected of metastasis in the mentioned areas, a biopsy lesion is performed and a sample is sent for pathological examination..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of the study will be published as an article

When:
6 months after the publication of the article

To whom:
Academic researcher groups

Conditions:
Share experiences

Where to obtain:
Dr. Farzad vaghef Davari

How to obtain:
One month after receiving the email

Comments:
Email address: fvdavari@sina.tums.ac.ir</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzad Vaghef Davari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>+98 21 2213 5448</telephone>
        <email>fvdavari@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzad Vaghef Davari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>+98 21 2213 5448</telephone>
        <email>fvdavari@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Existence of confirmed gastric cancer in tissue biopsy
The tumor is T3 or higher on histological examination
The exact stage of the disease is diagnosed by CT scan with or without endosonography
Patients aged 20-75 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of metastases proven in histological or radiological examinations
Presence of tissue metastasis during surgery
Clear seeding to the peritoneum during surgery
Intolerance to general anesthesia
Existence of any contraindications for diagnostic laparoscopy
History of receiving any radiotherapy or adjuvant chemotherapy before diagnostic laparoscopy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C16.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of stomach, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At the beginning of the laparoscopy, the entire abdominal area, including the stomach, peritoneum, omentum, pelvis, and liver, is examined with a 30-degree camera, and if there is free fluid in the abdomen, the fluid will be sampled.In the absence of free fluid in the abdomen, Serous viscera in the abdomen and stomach are lavaged with 100 cc of normal saline and then the lavage fluid is aspirated and sent for cytological examination.Then all the peritoneum is examined and if there is any lesion suspected of metastasis in the mentioned areas, a biopsy lesion is performed and a sample is sent for pathological examination.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The result of sampling from omentum. Timepoint: one time  and 10 days after biopsy. Method of measurement: Based on biopsy results.</prim_outcome>
      <prim_outcome>The result of cytology of free fluid or abdominal lavage fluid. Timepoint: one time, 10 days after drawing the liquid. Method of measurement: Based on  the pathology result.</prim_outcome>
      <prim_outcome>Presence of ascites during surgery. Timepoint: Once and at the beginning of surgery. Method of measurement: Direct observation during surgery.</prim_outcome>
      <prim_outcome>Depth of penetration of tumor tissue in adjacent tissue layers. Timepoint: Once during surgery. Method of measurement: Direct observation during surgery.</prim_outcome>
      <prim_outcome>Extent of adjacent or distant lymph nodes involved by tumor tissue. Timepoint: Once during surgery. Method of measurement: Direct observation during surgery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-19</approval_date>
        <contact_name>Ethics Committee in Research of Imam Khomeini Hospital Complex</contact_name>
        <contact_address>Imam Khomeini Hospital Complex,Dr. Gharib Street,At the end of Keshavarz Blvd,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
