Registry on NEN Patients and COVID-19

June 27, 2023 updated by: European Institute of Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cristina Mazzon, Ph.D.
  • Phone Number: +39(0)294372686

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20141
        • Recruiting
        • European Institute of Oncology, IEO, IRCCS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicola Fazio, MD, PhD
        • Sub-Investigator:
          • Francesca Spada, MD, PhD
        • Sub-Investigator:
          • Lorenzo Gervaso, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
01/2020 - 12/2020
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
01/2020 - 12/2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major demographic features
Time Frame: 01/2020 - 12/2020
demographic features of SARS-CoV-2 infected NEN patients
01/2020 - 12/2020
type of NEN
Time Frame: 01/2020 - 12/2020
Rate of grade, stage, status and primary site of NENs
01/2020 - 12/2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 15, 2023

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO-1291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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