Official Title
InterNaTional rEgistry oN Sars-cov-2posItiVe nEuroendocrine Neoplasm Patients (INTENSIVE)
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.

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.

Recruiting
Neuroendocrine Tumors
COVID-19
Eligibility 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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

European Institute of Oncology, IEO, IRCCS
Milan, MI, Italy

Investigator: Darina Tamayo, PharmSC.
Contact: +390294372686
darina.tamayo@ieo.it

Contacts

Darina Tamayo, PharmSc
+39(0)294372686
darina.tamayo@ieo.it

Cristina Mazzon, Ph.D.
+39(0)294372686

Nicola Fazio, M.D., Ph.D., Principal Investigator
European Institute of Oncology, IEO, IRCCS

European Institute of Oncology
NCT Number
Keywords
NEN
NET
NEC
Covid-19
SARS-CoV-2
Coronavirus
MeSH Terms
COVID-19
Neuroendocrine Tumors