<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/NCT02994758</url>
  </required_header>
  <id_info>
    <org_study_id>None yet</org_study_id>
    <nct_id>NCT02994758</nct_id>
  </id_info>
  <brief_title>Development of Diagnostics and Treatment of Urological Cancers</brief_title>
  <acronym>DEDUCER</acronym>
  <official_title>Development of Diagnostics and Treatment of Urological Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central 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>
      The purpose of the study is to evaluate whether state-of-the-art technologies such and next&#xD;
      generation sequencing and drug sensitivity and resistance testing of patient derived tumour&#xD;
      tissue can facilitate research translation and improve outcome of urologic cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Access to high-quality clinical patient material (e.g. tissue of primary tumor and&#xD;
      metastasis, plasma and urine) linked to comprehensive registry and clinical data and&#xD;
      molecular characterization of the patient material using state-of-the-art technologies (e.g.&#xD;
      NGS, transcriptomics, imaging, DSRT) will facilitate a more rapid translation of basic&#xD;
      research innovations into clinical care (diagnostics, imaging, therapeutics) and result in&#xD;
      improved outcome of patients suffering from urologic cancers (&quot;personalized medicine&quot;).&#xD;
&#xD;
      The principal aim of the project is to establish a framework and infrastructure for the&#xD;
      systematic collection and interpretation of biological patient samples. Similarly, the&#xD;
      investigators aim to establish the format how the related clinical and research data can be&#xD;
      made readily accessible for both clinicians and researchers without compromising patient&#xD;
      privacy. The key objectives of the project are to facilitate research translation and to&#xD;
      improve outcome of urologic cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Successful clinical translation</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The magnitude of successful clinical translation is measured by the number of times project-derived personalized medicine has impacted patients care by application of novel and existing biomarkers and therapies (e.g. sequencing, DSRT) by 2020</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful pre-clinical translation</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Successful pre-clinical translation, the magnitude of which is measured by the number of times project-derived potential druggable targets or able to re-purpose treatment options were identified within the project by 2020.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Translation of preclinical data into clinically useful data.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Translation of preclinical data into clinically useful data. The success of which is measured by the number of times preclinical data (e.g. sequencing, DSRT) was transformed into clinically useful form within 4 weeks from the time the initial sampling of the specimen was done.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of representative cell models developed from clinical samples.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Representativeness is based on the genetics of the cell model and the parental tumor</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Prostate Carcinoma</condition>
  <condition>Kidney Cancer</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Testicular Cancer</condition>
  <condition>Penile Cancer</condition>
  <arm_group>
    <arm_group_label>Personalised medicine arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a prospective &quot;n-of-1&quot; type of trial where every patient is his/her own control. This is a study further developing the translational use of an existing framework and infrastructure for systematic sample collection an analytics previously established in the HUB project incorporating NGS and DSRT into clinical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalised treatment</intervention_name>
    <description>Treatment based on NGS or DSRT</description>
    <arm_group_label>Personalised medicine arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is able to provide written informed consent and is at least 18 years of&#xD;
             age&#xD;
&#xD;
          2. The patient must have a verified diagnosis of an urologic cancer by a board-certified&#xD;
             clinician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient is not willing to provide a written informed consent&#xD;
&#xD;
          2. The patient has a severe psychiatric illness, imprisonment or mental impairment&#xD;
             inflicting on ability to give informed consent&#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>Antti S Rannikko, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antti S Rannikko, MD, PhD</last_name>
    <phone>+35894711</phone>
    <email>antti.rannikko@hus.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <state>Uusimaa</state>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antti s Rannikko, MD, PhD</last_name>
      <email>antti.rannikko@hus.fi</email>
    </contact>
    <investigator>
      <last_name>Östling Päivi, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tuomas Mirtti, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Petri Bono, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Harry Nisen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katriina Peltola, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olli Kallioniemi, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jukka Sairanen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Petrus Järvinen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henrikki Santti, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anssi Petas, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mika Matikainen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Riikka Järvinen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hanna Vasarainen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tuomas Kilpeläinen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mauri Kouri, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tapio Utriainen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kimmo Taari, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vesa Rahkama, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Erickson, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Saeed Khalid, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maija Puhka, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vilja Pietiäinen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lassi Paavolainen, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dmitry Bykhov, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Teijo Pellinen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sami Blom, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Taija af Hällström, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kevin Sandeman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anu Kenttämies, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Outi Oksanen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jarkko Pajarinen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jari Siironen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <results_reference>
    <citation>Saeed K, Rahkama V, Eldfors S, Bychkov D, Mpindi JP, Yadav B, Paavolainen L, Aittokallio T, Heckman C, Wennerberg K, Peehl DM, Horvath P, Mirtti T, Rannikko A, Kallioniemi O, Ostling P, Af Hallstrom TM. Comprehensive Drug Testing of Patient-derived Conditionally Reprogrammed Cells from Castration-resistant Prostate Cancer. Eur Urol. 2017 Mar;71(3):319-327. doi: 10.1016/j.eururo.2016.04.019. Epub 2016 May 6.</citation>
    <PMID>27160946</PMID>
  </results_reference>
  <results_reference>
    <citation>Saeed K, Ojamies P, Pellinen T, Eldfors S, Turkki R, Lundin J, Jarvinen P, Nisen H, Taari K, Af Hallstrom TM, Rannikko A, Mirtti T, Kallioniemi O, Ostling P. Clonal heterogeneity influences drug responsiveness in renal cancer assessed by ex vivo drug testing of multiple patient-derived cancer cells. Int J Cancer. 2019 Mar 15;144(6):1356-1366. doi: 10.1002/ijc.31815. Epub 2018 Nov 4.</citation>
    <PMID>30125350</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Antti Rannikko</investigator_full_name>
    <investigator_title>Senior consultant, urology</investigator_title>
  </responsible_party>
  <keyword>Prostate</keyword>
  <keyword>bladder</keyword>
  <keyword>renal</keyword>
  <keyword>NGS</keyword>
  <keyword>DSRT</keyword>
  <keyword>drug screening</keyword>
  <keyword>sequencing</keyword>
  <keyword>personalised medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Testicular Neoplasms</mesh_term>
    <mesh_term>Penile Neoplasms</mesh_term>
    <mesh_term>Urologic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02994758
org study id: None yet
nct id: NCT02994758
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate whether state-of-the-art technologies such and next
      generation sequencing and drug sensitivity and resistance testing of patient derived tumour
      tissue can facilitate research translation and improve outcome of urologic cancers.
Access to high-quality clinical patient material (e.g. tissue of primary tumor and
      metastasis, plasma and urine) linked to comprehensive registry and clinical data and
      molecular characterization of the patient material using state-of-the-art technologies (e.g.
      NGS, transcriptomics, imaging, DSRT) will facilitate a more rapid translation of basic
      research innovations into clinical care (diagnostics, imaging, therapeutics) and result in
      improved outcome of patients suffering from urologic cancers ("personalized medicine").

      The principal aim of the project is to establish a framework and infrastructure for the
      systematic collection and interpretation of biological patient samples. Similarly, the
      investigators aim to establish the format how the related clinical and research data can be
      made readily accessible for both clinicians and researchers without compromising patient
      privacy. The key objectives of the project are to facilitate research translation and to
      improve outcome of urologic cancers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful clinical translation
time frame: Up to 24 months
description: The magnitude of successful clinical translation is measured by the number of times project-derived personalized medicine has impacted patients care by application of novel and existing biomarkers and therapies (e.g. sequencing, DSRT) by 2020
measure: Successful pre-clinical translation
time frame: Up to 24 months
description: Successful pre-clinical translation, the magnitude of which is measured by the number of times project-derived potential druggable targets or able to re-purpose treatment options were identified within the project by 2020.
measure: Translation of preclinical data into clinically useful data.
time frame: Up to 24 months
description: Translation of preclinical data into clinically useful data. The success of which is measured by the number of times preclinical data (e.g. sequencing, DSRT) was transformed into clinically useful form within 4 weeks from the time the initial sampling of the specimen was done.
measure: Number of representative cell models developed from clinical samples.
time frame: Up to 24 months
description: Representativeness is based on the genetics of the cell model and the parental tumor
arm group label: Personalised medicine arm
arm group type: Other
description: This is a prospective "n-of-1" type of trial where every patient is his/her own control. This is a study further developing the translational use of an existing framework and infrastructure for systematic sample collection an analytics previously established in the HUB project incorporating NGS and DSRT into clinical care.
intervention type: Other
intervention name: Personalised treatment
description: Treatment based on NGS or DSRT
arm group label: Personalised medicine arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antti S Rannikko, MD, PhD
role: Principal Investigator
affiliation: Helsinki University Central Hospital
last name: Antti S Rannikko, MD, PhD
phone: +35894711
email: antti.rannikko@hus.fi
facility: 
status: Recruiting
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country: Finland
citation: Saeed K, Rahkama V, Eldfors S, Bychkov D, Mpindi JP, Yadav B, Paavolainen L, Aittokallio T, Heckman C, Wennerberg K, Peehl DM, Horvath P, Mirtti T, Rannikko A, Kallioniemi O, Ostling P, Af Hallstrom TM. Comprehensive Drug Testing of Patient-derived Conditionally Reprogrammed Cells from Castration-resistant Prostate Cancer. Eur Urol. 2017 Mar;71(3):319-327. doi: 10.1016/j.eururo.2016.04.019. Epub 2016 May 6.
PMID: 27160946
citation: Saeed K, Ojamies P, Pellinen T, Eldfors S, Turkki R, Lundin J, Jarvinen P, Nisen H, Taari K, Af Hallstrom TM, Rannikko A, Mirtti T, Kallioniemi O, Ostling P. Clonal heterogeneity influences drug responsiveness in renal cancer assessed by ex vivo drug testing of multiple patient-derived cancer cells. Int J Cancer. 2019 Mar 15;144(6):1356-1366. doi: 10.1002/ijc.31815. Epub 2018 Nov 4.
PMID: 30125350
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Antti Rannikko
investigator title: Senior consultant, urology
mesh term: Carcinoma
mesh term: Kidney Neoplasms
mesh term: Testicular Neoplasms
mesh term: Penile Neoplasms
mesh term: Urologic Neoplasms
sharing ipd: Undecided