<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/NCT03821870</url>
  </required_header>
  <id_info>
    <org_study_id>TIP</org_study_id>
    <nct_id>NCT03821870</nct_id>
  </id_info>
  <brief_title>Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity</brief_title>
  <acronym>TIP</acronym>
  <official_title>Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vejle 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      It will be investigated whether it is possible to predict the effect or lack of effect of&#xD;
      first-line treatment by analysing cancer cells from the individual patient receiving standard&#xD;
      first line treatment. Also, the feasibility of selecting second-line therapy based on&#xD;
      pre-treatment biopsies will be investigated.&#xD;
&#xD;
      Cells from pancreatic cancer will be grown in the laboratory to form small, circulating&#xD;
      tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to&#xD;
      different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of&#xD;
      sensitivity in the specific patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">February 22, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Predictive value of in-vitro testing</measure>
    <time_frame>2 months</time_frame>
    <description>Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)</measure>
    <time_frame>Every 2 months during treatment up to 180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS)</measure>
    <time_frame>Every 2 months up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Metastatic Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <description>Standard first line treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Inditreat</intervention_name>
    <description>Tumoroid formation and drug sensitivity analysis</description>
    <arm_group_label>Standard treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental drug</intervention_name>
    <description>Second line treatment based on drug sensitivity analysis</description>
    <arm_group_label>Standard treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Liver biopsy and blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic pancreatic cancer eligible for chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-resectable pancreatic cancer&#xD;
&#xD;
               -  Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or&#xD;
                  metastasis)&#xD;
&#xD;
               -  If only biopsy from metastasis can be obtained, the patient must have a&#xD;
                  previously resected or image proven tumor of the pancreas&#xD;
&#xD;
               -  Deemed non-resectable at a multidisciplinary conference&#xD;
&#xD;
          -  Candidate to standard systemic therapy, defined as one of&#xD;
&#xD;
               -  Gemcitabine monotherapy,&#xD;
&#xD;
               -  Gemcitabine and nab-paclitaxel combination,&#xD;
&#xD;
               -  Gemcitabine and capecitabine combination,&#xD;
&#xD;
               -  5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or&#xD;
&#xD;
               -  New standard treatments approved by the multidisciplinary cancer group 'Danish&#xD;
                  Pancreatic Cancer Group' in the inclusion period.&#xD;
&#xD;
          -  Measurable disease according to RECIST 1.1&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Adequate bone marrow, liver and renal function allowing systemic chemotherapy&#xD;
&#xD;
               -  Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l&#xD;
&#xD;
               -  Bilirubin ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper&#xD;
                  normal value&#xD;
&#xD;
               -  Calculated or measured renal glomerular filtration rate at least 30 mL/min&#xD;
&#xD;
          -  Contraception for fertile women and for male patients with a fertile partner.&#xD;
             Intrauterine device, vasectomy of a female subject's male partner or hormonal&#xD;
             contraceptive are acceptable&#xD;
&#xD;
          -  Written and orally informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Potentially resectable disease&#xD;
&#xD;
               -  Incapacity, frailty, disability, or comorbidity to a degree that according to the&#xD;
                  investigator is not compatible with participation in the protocol&#xD;
&#xD;
               -  Other active malignant disease requiring therapy&#xD;
&#xD;
               -  Other systemic anti-cancer therapy (palliative radiotherapy is allowed)&#xD;
&#xD;
               -  Pregnant (positive pregnancy test) or breast feeding women&#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>Lars Henrik Jensen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vejle Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departmen of Oncology, Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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/NCT03821870
org study id: TIP
nct id: NCT03821870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It will be investigated whether it is possible to predict the effect or lack of effect of
      first-line treatment by analysing cancer cells from the individual patient receiving standard
      first line treatment. Also, the feasibility of selecting second-line therapy based on
      pre-treatment biopsies will be investigated.

      Cells from pancreatic cancer will be grown in the laboratory to form small, circulating
      tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to
      different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of
      sensitivity in the specific patient.
observational model: Cohort
time perspective: Prospective
measure: Predictive value of in-vitro testing
time frame: 2 months
description: Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy
measure: Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)
time frame: Every 2 months during treatment up to 180 days
measure: Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS)
time frame: Every 2 months up to 12 months
arm group label: Standard treatment
description: Standard first line treatment
intervention type: Diagnostic Test
intervention name: Inditreat
description: Tumoroid formation and drug sensitivity analysis
arm group label: Standard treatment
intervention type: Drug
intervention name: Experimental drug
description: Second line treatment based on drug sensitivity analysis
arm group label: Standard treatment
Liver biopsy and blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Henrik Jensen, MD, PhD
role: Study Chair
affiliation: Vejle Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No