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Registry on NEN Patients and COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04444401
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Brief Summary:

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.


Condition or disease
Neuroendocrine Tumors COVID-19

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: InterNaTional rEgistry oN Sars-cov-2posItiVe nEuroendocrine Neoplasm Patients (INTENSIVE)
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation between clinical parameters and SARS-CoV-2 infection [ Time Frame: 01/2020 - 12/2020 ]
    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.

  2. Clinical outcome of SARS-CoV-2 Infection [ Time Frame: 01/2020 - 12/2020 ]
    To evaluate the impact of SARS-CoV-2 Infection in NEN patients


Secondary Outcome Measures :
  1. major demographic features [ Time Frame: 01/2020 - 12/2020 ]
    demographic features of SARS-CoV-2 infected NEN patients

  2. type of NEN [ Time Frame: 01/2020 - 12/2020 ]
    Rate of grade, stage, status and primary site of NENs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a NEN of any type with a positive SARS-CoV-2 swab (RT-PCR).
Criteria

Inclusion Criteria:

  • Patients > 18 y.o.
  • Patients with a NEN of any type with a positive SARS-CoV-2 swab (RT-PCR).
  • Patients with SARS-CoV-2 positivity (RT-PCR) who are asymptomatic or with symptoms/signs of COVID-19.
  • Patients with a NEN on active treatment.
  • Patients with macroscopic evidence of NEN or with no evidence of NEN (if they received surgical +/- locoregional non-surgical treatments within the last 2 months)
  • Able to provide signed written informed consent

Exclusion Criteria:

  • Patients with NEN and symptoms suspected for COVID-19 who did not undergo SARS-CoV-2 swab (RT-PCR).
  • Patients with small cell lung cancer.
  • Patients with non-pure NEN (e.g. MiNEN).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04444401


Contacts
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Contact: Darina Tamayo, PharmSc +39(0)294372686 darina.tamayo@ieo.it
Contact: Cristina Mazzon, Ph.D. +39(0)294372686

Locations
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Italy
European Institute of Oncology, IEO, IRCCS Recruiting
Milan, MI, Italy, 20141
Contact: Darina Tamayo, PharmSC.    +390294372686    darina.tamayo@ieo.it   
Contact: Cristina Mazzon, Ph.D.    +390294372686    cristina.mazzon@ieo.it   
Principal Investigator: Nicola Fazio, MD, PhD         
Sub-Investigator: Francesca Spada, MD, PhD         
Sub-Investigator: Lorenzo Gervaso, MD         
Sponsors and Collaborators
European Institute of Oncology
Investigators
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Principal Investigator: Nicola Fazio, M.D., Ph.D. European Institute of Oncology, IEO, IRCCS
  Study Documents (Full-Text)

Documents provided by European Institute of Oncology:
Informed Consent Form  [PDF] May 12, 2020

Publications:
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Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT04444401    
Other Study ID Numbers: IEO-1291
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Institute of Oncology:
NEN
NET
NEC
COVID-19
SARS-CoV-2
Coronavirus
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue