<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/NCT03019471</url>
  </required_header>
  <id_info>
    <org_study_id>NL55080.068.15</org_study_id>
    <nct_id>NCT03019471</nct_id>
  </id_info>
  <brief_title>Non Invasive Cancer Test (NICT): a Proof of Principle Study.</brief_title>
  <acronym>NICT-NIPT-CA</acronym>
  <official_title>Non Invasive Cancer Test (NICT): a Proof of Principle Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to collect tumor DNA out of blood of cancer patients. If this is&#xD;
      successful this could lead to the development of a cancer test in blood in the future, which&#xD;
      is less invasive than current diagnostic methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>ctDNA</measure>
    <time_frame>One year</time_frame>
    <description>Demonstrate the presence or absence of ctDNA in patients plasma. Examine if there us a sufficient concentration of ctDNA in the plasma to reliably diagnose cancer and determine the CNV</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Neoplasmata</condition>
  <arm_group>
    <arm_group_label>Lung cancer</arm_group_label>
    <description>Isolate Tumor DNA from the patients blood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast cancer</arm_group_label>
    <description>Isolate Tumor DNA from the patients blood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <description>Isolate Tumor DNA from the patients blood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glioma</arm_group_label>
    <description>Isolate Tumor DNA from the patients blood.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Isolation of tumor DNA</intervention_name>
    <arm_group_label>Breast cancer</arm_group_label>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Glioma</arm_group_label>
    <arm_group_label>Lung cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer,&#xD;
             non-small cell lung cancer and anaplastic glioblastoma, before start of radiation&#xD;
             therapy, chemoradiation or chemotherapy.&#xD;
&#xD;
          2. Patients age &gt; 18 years, willing and able to comply with the protocol as judged by the&#xD;
             investigator with a signed informed consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer,&#xD;
             non-small cell lung cancer and anaplastic glioblastoma, before start of radiation&#xD;
             therapy, chemoradiation or chemotherapy.&#xD;
&#xD;
          2. Patients age &gt; 18 years, willing and able to comply with the protocol as judged by the&#xD;
             investigator with a signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of malignant disease other than the disease under study, with&#xD;
             an exception for adequately treated squamous cell carcinoma of the skin, basal cell&#xD;
             carcinoma of the skin and in situ cervix carcinoma.&#xD;
&#xD;
          2. Pregnancy&#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>Christine C. De Die-Smulders, Prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Geneticist in MUMC+</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Merryn M. Macville, Dr.</last_name>
    <phone>+31-43-3875843</phone>
    <email>m.macville@mumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Job J. Verdonschot, Drs.</last_name>
    <phone_ext>+31-43-3877093</phone_ext>
    <email>job-verdonschot@mumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M. Eijck-Vievermans</last_name>
      <phone>+313876447</phone>
      <email>margo.vievermans@mumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03019471
org study id: NL55080.068.15
nct id: NCT03019471
lead sponsor: 
has dmc: Yes
The investigators aim to collect tumor DNA out of blood of cancer patients. If this is
      successful this could lead to the development of a cancer test in blood in the future, which
      is less invasive than current diagnostic methods.
observational model: Cohort
time perspective: Prospective
measure: ctDNA
time frame: One year
description: Demonstrate the presence or absence of ctDNA in patients plasma. Examine if there us a sufficient concentration of ctDNA in the plasma to reliably diagnose cancer and determine the CNV
arm group label: Lung cancer
description: Isolate Tumor DNA from the patients blood.
arm group label: Breast cancer
description: Isolate Tumor DNA from the patients blood.
arm group label: Colorectal cancer
description: Isolate Tumor DNA from the patients blood.
arm group label: Glioma
description: Isolate Tumor DNA from the patients blood.
intervention type: Genetic
intervention name: Isolation of tumor DNA
arm group label: Breast cancer
arm group label: Colorectal cancer
arm group label: Glioma
arm group label: Lung cancer
Blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine C. De Die-Smulders, Prof. dr.
role: Principal Investigator
affiliation: Clinical Geneticist in MUMC+
last name: Merryn M. Macville, Dr.
phone: +31-43-3875843
email: m.macville@mumc.nl
last name: Job J. Verdonschot, Drs.
phone ext: +31-43-3877093
email: job-verdonschot@mumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No