<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/NCT03750175</url>
  </required_header>
  <id_info>
    <org_study_id>KFE1713</org_study_id>
    <nct_id>NCT03750175</nct_id>
  </id_info>
  <brief_title>OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -</brief_title>
  <acronym>OPTIPAL-II</acronym>
  <official_title>OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karen-Lise Garm Spindler</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will investigate the feasibility and clinical value of using circulating&#xD;
      tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic&#xD;
      colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible&#xD;
      and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody&#xD;
      therapy&#xD;
&#xD;
      Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma&#xD;
      during therapy and at time of progression&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</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>Feasibility of ctDNA analysis for RAS mutation analysis</measure>
    <time_frame>maximum 7 days</time_frame>
    <description>Feasibility measures&#xD;
Identification of wildtype or mutated status and results delivered to clinicians&#xD;
Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days&#xD;
Detailed mutation type characterization is provided retrospectively.&#xD;
Failure parameters&#xD;
Quality of samples; PB &gt; 5%, CPP1 major loss &lt; 10%&#xD;
Transportation &gt; 3 week days&#xD;
Analysis &gt; 3 working days&#xD;
Total results delivered &gt; 7 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retrospective concordance analysis</measure>
    <time_frame>By end of study, expected after 3 years</time_frame>
    <description>Retrospective comparison of tumor mutation and plasma mutation analysis at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>1 year</time_frame>
    <description>Rate of disease control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>3 years</time_frame>
    <description>Overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance mutations</measure>
    <time_frame>At time of progression, data analysis expected after 3 years</time_frame>
    <description>Rate of Ectoderm mutations at time of progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lead time</measure>
    <time_frame>At time of progression, data analysis expected after 3 years</time_frame>
    <description>Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">49</enrollment>
  <condition>Colorectal Cancer Metastatic</condition>
  <condition>Circulating Tumor DNA</condition>
  <condition>KRAS Gene Mutation</condition>
  <condition>NRAS Gene Mutation</condition>
  <condition>BRAF Gene Mutation</condition>
  <condition>Epidermal Growth Factor Receptor Inhibitor</condition>
  <arm_group>
    <arm_group_label>Colorectal cancer patients</arm_group_label>
    <description>Clinical utility of ctDNA analysis for treatment decision&#xD;
Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plasma circulating DNA analysis</intervention_name>
    <description>Clinical utility of ctDNA analysis for treatment decision</description>
    <arm_group_label>Colorectal cancer patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samles for circulating DNA analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic colorectal cancer and indication for palliative chemotherapy with&#xD;
        potential anti-EGFR monoclonal antibody.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Histopathologically verified metastatic colorectal cancer&#xD;
&#xD;
          -  Indication for systemic palliative treatment with standard Anti-EGFR monoclonal&#xD;
             antibodies&#xD;
&#xD;
          -  Fit for therapy with EGFR inhibition&#xD;
&#xD;
          -  Consent to treatment and sampling&#xD;
&#xD;
          -  Measureable disease according to RECIST v 1.1&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  PS &gt; 2&#xD;
&#xD;
          -  Significant other cancer disease within 5 years of inclusion&#xD;
&#xD;
          -  Conditions precluding sampling during therapy and treatment breaks.&#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>Karen-Lise G Spindler</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Oncology, AUH, Dk</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Karen-Lise Garm Spindler</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT03750175
org study id: KFE1713
nct id: NCT03750175
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The present study will investigate the feasibility and clinical value of using circulating
      tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic
      colorectal cancer.
The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible
      and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody
      therapy

      Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma
      during therapy and at time of progression
observational model: Cohort
time perspective: Prospective
measure: Feasibility of ctDNA analysis for RAS mutation analysis
time frame: maximum 7 days
description: Feasibility measures
Identification of wildtype or mutated status and results delivered to clinicians
Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days
Detailed mutation type characterization is provided retrospectively.
Failure parameters
Quality of samples; PB > 5%, CPP1 major loss < 10%
Transportation > 3 week days
Analysis > 3 working days
Total results delivered > 7 days.
measure: Retrospective concordance analysis
time frame: By end of study, expected after 3 years
description: Retrospective comparison of tumor mutation and plasma mutation analysis at baseline
measure: Disease control rate
time frame: 1 year
description: Rate of disease control
measure: OS
time frame: 3 years
description: Overall survival rate
measure: Resistance mutations
time frame: At time of progression, data analysis expected after 3 years
description: Rate of Ectoderm mutations at time of progression
measure: Lead time
time frame: At time of progression, data analysis expected after 3 years
description: Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.
arm group label: Colorectal cancer patients
description: Clinical utility of ctDNA analysis for treatment decision
Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer
intervention type: Other
intervention name: Plasma circulating DNA analysis
description: Clinical utility of ctDNA analysis for treatment decision
arm group label: Colorectal cancer patients
Plasma samles for circulating DNA analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen-Lise G Spindler
role: Study Chair
affiliation: Department of Oncology, AUH, Dk
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Karen-Lise Garm Spindler
investigator title: Professor
mesh term: Colorectal Neoplasms
sharing ipd: No