<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/NCT04444401</url>
  </required_header>
  <id_info>
    <org_study_id>IEO-1291</org_study_id>
    <nct_id>NCT04444401</nct_id>
  </id_info>
  <brief_title>Registry on NEN Patients and COVID-19</brief_title>
  <official_title>InterNaTional rEgistry oN Sars-cov-2posItiVe nEuroendocrine Neoplasm Patients (INTENSIVE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Institute of Oncology</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>
      A huge number of initiatives about COVID-19 are ongoing and a growing number of publications&#xD;
      regard the correlation between cancer patients in general and SARS-CoV-2 infection. Although&#xD;
      it has been reported that cancer patients are at a higher risk of SARS-CoV-2 infection and&#xD;
      COVID-19 complications, data collection about cases of NEN patients SARS-CoV-2 positive are&#xD;
      scattered and related to single countries or institutions. Because of that and due to the&#xD;
      rarity and heterogeneity of NEN it will be hard to have homogeneous, reliable, representative&#xD;
      and reproducible data for drawing adequate clinical recommendations about NEN patients and&#xD;
      COVID-19.&#xD;
&#xD;
      Therefore we propose a global collection of data through an international database to&#xD;
      describe and monitor NEN patients with SARS-CoV-2 infection. This retrospective/prospective&#xD;
      collection of data can create a solid basis to check frequence of events, clinical&#xD;
      management, clinical outcome, demographic, geographical, clinical and biological&#xD;
      correlations. This will be helpful for the clinical and scientific community to get reliable&#xD;
      information for a homogeneous clinical management of NEN patients during COVID-19 pandemic.&#xD;
&#xD;
      The main goal is to get the as wide as possible representativity of the world situation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the end of December 2019, several cases of pneumonia of unknown origin were diagnosed in&#xD;
      Wuhan, in the province of Hubei, China. These cases have been linked to a new&#xD;
      beta-coronavirus (COVID-19), identified with RT-PCR method from samples taken from the&#xD;
      bronchoalveolar samples of a patient with pneumonia of unknown etiology in the Wuhan&#xD;
      Jinyintan hospital. Severe acute respiratory coronavirus 2 syndrome (SARS-CoV-2) has spread&#xD;
      rapidly worldwide causing a pandemic.&#xD;
&#xD;
      Cancer patients are considered at greater risk of viral infection and its complications,&#xD;
      including SARS-CoV-2. Certain types of cancer, such as thoracic cancers, and underlying&#xD;
      clinical conditions, for instance concomitant immunosuppressive therapies or immune-related&#xD;
      comorbidities, are factors potentially predisposing to an increased risk of infection and&#xD;
      eventually complications of COVID-19.&#xD;
&#xD;
      In this context, it is difficult to understand where and how to identify patients with&#xD;
      neuroendocrine neoplasia (NEN).&#xD;
&#xD;
      We propose a global collection of data through an international database to describe and&#xD;
      monitor NEN patients with COVID-19. This retrospective/prospective collection of data can&#xD;
      create a large basis to check frequency of events, clinical management, clinical outcome,&#xD;
      demographic, geographical, clinical and biological correlations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between clinical parameters and SARS-CoV-2 infection</measure>
    <time_frame>01/2020 - 12/2020</time_frame>
    <description>To evaluate the correlation between SARS-CoV-2 infection and the following parameters: major comorbidities, severe overall events (including death), chemotherapy for neuroendocrine tumor (NET), chemotherapy for neuroendocrine carcinoma (NEC), everolimus therapy, immunotherapy, peptide receptor radionuclide therapy (PRRT) and surgery or radiotherapy within the last 2 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical outcome of SARS-CoV-2 Infection</measure>
    <time_frame>01/2020 - 12/2020</time_frame>
    <description>To evaluate the impact of SARS-CoV-2 Infection in NEN patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>major demographic features</measure>
    <time_frame>01/2020 - 12/2020</time_frame>
    <description>demographic features of SARS-CoV-2 infected NEN patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>type of NEN</measure>
    <time_frame>01/2020 - 12/2020</time_frame>
    <description>Rate of grade, stage, status and primary site of NENs</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a NEN of any type with a positive SARS-CoV-2 swab (RT-PCR).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 y.o.&#xD;
&#xD;
          -  Patients with a NEN of any type with a positive SARS-CoV-2 swab (RT-PCR).&#xD;
&#xD;
          -  Patients with SARS-CoV-2 positivity (RT-PCR) who are asymptomatic or with&#xD;
             symptoms/signs of COVID-19.&#xD;
&#xD;
          -  Patients with a NEN on active treatment.&#xD;
&#xD;
          -  Patients with macroscopic evidence of NEN or with no evidence of NEN (if they received&#xD;
             surgical +/- locoregional non-surgical treatments within the last 2 months)&#xD;
&#xD;
          -  Able to provide signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with NEN and symptoms suspected for COVID-19 who did not undergo SARS-CoV-2&#xD;
             swab (RT-PCR).&#xD;
&#xD;
          -  Patients with small cell lung cancer.&#xD;
&#xD;
          -  Patients with non-pure NEN (e.g. MiNEN).&#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>Nicola Fazio, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>European Institute of Oncology, IEO, IRCCS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Darina Tamayo, PharmSc</last_name>
    <phone>+39(0)294372686</phone>
    <email>darina.tamayo@ieo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cristina Mazzon, Ph.D.</last_name>
    <phone>+39(0)294372686</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>European Institute of Oncology, IEO, IRCCS</name>
      <address>
        <city>Milan</city>
        <state>MI</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Darina Tamayo, PharmSC.</last_name>
      <phone>+390294372686</phone>
      <email>darina.tamayo@ieo.it</email>
    </contact>
    <contact_backup>
      <last_name>Cristina Mazzon, Ph.D.</last_name>
      <phone>+390294372686</phone>
      <email>cristina.mazzon@ieo.it</email>
    </contact_backup>
    <investigator>
      <last_name>Nicola Fazio, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francesca Spada, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lorenzo Gervaso, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.</citation>
    <PMID>31978945</PMID>
  </reference>
  <reference>
    <citation>Yu J, Ouyang W, Chua MLK, Xie C. SARS-CoV-2 Transmission in Patients With Cancer at a Tertiary Care Hospital in Wuhan, China. JAMA Oncol. 2020 Jul 1;6(7):1108-1110. doi: 10.1001/jamaoncol.2020.0980.</citation>
    <PMID>32211820</PMID>
  </reference>
  <reference>
    <citation>Al-Shamsi HO, Alhazzani W, Alhuraiji A, Coomes EA, Chemaly RF, Almuhanna M, Wolff RA, Ibrahim NK, Chua MLK, Hotte SJ, Meyers BM, Elfiki T, Curigliano G, Eng C, Grothey A, Xie C. A Practical Approach to the Management of Cancer Patients During the Novel Coronavirus Disease 2019 (COVID-19) Pandemic: An International Collaborative Group. Oncologist. 2020 Jun;25(6):e936-e945. doi: 10.1634/theoncologist.2020-0213. Epub 2020 Apr 27.</citation>
    <PMID>32243668</PMID>
  </reference>
  <reference>
    <citation>Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.</citation>
    <PMID>32066541</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NEN</keyword>
  <keyword>NET</keyword>
  <keyword>NEC</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: version 1.0</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT04444401/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: version 1.1</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT04444401/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT04444401/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04444401
org study id: IEO-1291
nct id: NCT04444401
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A huge number of initiatives about COVID-19 are ongoing and a growing number of publications
      regard the correlation between cancer patients in general and SARS-CoV-2 infection. Although
      it has been reported that cancer patients are at a higher risk of SARS-CoV-2 infection and
      COVID-19 complications, data collection about cases of NEN patients SARS-CoV-2 positive are
      scattered and related to single countries or institutions. Because of that and due to the
      rarity and heterogeneity of NEN it will be hard to have homogeneous, reliable, representative
      and reproducible data for drawing adequate clinical recommendations about NEN patients and
      COVID-19.

      Therefore we propose a global collection of data through an international database to
      describe and monitor NEN patients with SARS-CoV-2 infection. This retrospective/prospective
      collection of data can create a solid basis to check frequence of events, clinical
      management, clinical outcome, demographic, geographical, clinical and biological
      correlations. This will be helpful for the clinical and scientific community to get reliable
      information for a homogeneous clinical management of NEN patients during COVID-19 pandemic.

      The main goal is to get the as wide as possible representativity of the world situation.
At the end of December 2019, several cases of pneumonia of unknown origin were diagnosed in
      Wuhan, in the province of Hubei, China. These cases have been linked to a new
      beta-coronavirus (COVID-19), identified with RT-PCR method from samples taken from the
      bronchoalveolar samples of a patient with pneumonia of unknown etiology in the Wuhan
      Jinyintan hospital. Severe acute respiratory coronavirus 2 syndrome (SARS-CoV-2) has spread
      rapidly worldwide causing a pandemic.

      Cancer patients are considered at greater risk of viral infection and its complications,
      including SARS-CoV-2. Certain types of cancer, such as thoracic cancers, and underlying
      clinical conditions, for instance concomitant immunosuppressive therapies or immune-related
      comorbidities, are factors potentially predisposing to an increased risk of infection and
      eventually complications of COVID-19.

      In this context, it is difficult to understand where and how to identify patients with
      neuroendocrine neoplasia (NEN).

      We propose a global collection of data through an international database to describe and
      monitor NEN patients with COVID-19. This retrospective/prospective collection of data can
      create a large basis to check frequency of events, clinical management, clinical outcome,
      demographic, geographical, clinical and biological correlations.
observational model: Case-Only
time perspective: Other
measure: Correlation between clinical parameters and SARS-CoV-2 infection
time frame: 01/2020 - 12/2020
description: To evaluate the correlation between SARS-CoV-2 infection and the following parameters: major comorbidities, severe overall events (including death), chemotherapy for neuroendocrine tumor (NET), chemotherapy for neuroendocrine carcinoma (NEC), everolimus therapy, immunotherapy, peptide receptor radionuclide therapy (PRRT) and surgery or radiotherapy within the last 2 months.
measure: Clinical outcome of SARS-CoV-2 Infection
time frame: 01/2020 - 12/2020
description: To evaluate the impact of SARS-CoV-2 Infection in NEN patients
measure: major demographic features
time frame: 01/2020 - 12/2020
description: demographic features of SARS-CoV-2 infected NEN patients
measure: type of NEN
time frame: 01/2020 - 12/2020
description: Rate of grade, stage, status and primary site of NENs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicola Fazio, M.D., Ph.D.
role: Principal Investigator
affiliation: European Institute of Oncology, IEO, IRCCS
last name: Darina Tamayo, PharmSc
phone: +39(0)294372686
email: darina.tamayo@ieo.it
last name: Cristina Mazzon, Ph.D.
phone: +39(0)294372686
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Italy
citation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PMID: 31978945
citation: Yu J, Ouyang W, Chua MLK, Xie C. SARS-CoV-2 Transmission in Patients With Cancer at a Tertiary Care Hospital in Wuhan, China. JAMA Oncol. 2020 Jul 1;6(7):1108-1110. doi: 10.1001/jamaoncol.2020.0980.
PMID: 32211820
citation: Al-Shamsi HO, Alhazzani W, Alhuraiji A, Coomes EA, Chemaly RF, Almuhanna M, Wolff RA, Ibrahim NK, Chua MLK, Hotte SJ, Meyers BM, Elfiki T, Curigliano G, Eng C, Grothey A, Xie C. A Practical Approach to the Management of Cancer Patients During the Novel Coronavirus Disease 2019 (COVID-19) Pandemic: An International Collaborative Group. Oncologist. 2020 Jun;25(6):e936-e945. doi: 10.1634/theoncologist.2020-0213. Epub 2020 Apr 27.
PMID: 32243668
citation: Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.
PMID: 32066541
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Neuroendocrine Tumors
provided document: 
provided document: 
provided document: 