Registry on NEN Patients and COVID-19

Recruiting

• Conditions: Neuroendocrine Tumors; COVID-19

• Registration Number: NCT04444401
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome of SARS-CoV-2 Infection	01/2020 - 12/2020	To evaluate the impact of SARS-CoV-2 Infection in NEN patients
Correlation between clinical parameters and SARS-CoV-2 infection	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.

Secondary Outcome Measures

Name	Time	Method
major demographic features	01/2020 - 12/2020	demographic features of SARS-CoV-2 infected NEN patients
type of NEN	01/2020 - 12/2020	Rate of grade, stage, status and primary site of NENs

Trial Locations

Locations (1)

European Institute of Oncology, IEO, IRCCS; 🇮🇹 Milan, MI, Italy