Registry on NEN Patients and COVID-19
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| ClinicalTrials.gov Identifier: NCT04444401 |
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Recruitment Status :
Recruiting
First Posted : June 23, 2020
Last Update Posted : August 13, 2021
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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 |
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| Neuroendocrine Tumors COVID-19 |
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 |
| 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 15, 2021 |
| Estimated Study Completion Date : | December 15, 2021 |
- 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.
- 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
- major demographic features [ Time Frame: 01/2020 - 12/2020 ]demographic features of SARS-CoV-2 infected NEN patients
- type of NEN [ Time Frame: 01/2020 - 12/2020 ]Rate of grade, stage, status and primary site of NENs
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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).
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
| Contact: Darina Tamayo, PharmSc | +39(0)294372686 | darina.tamayo@ieo.it | |
| Contact: Cristina Mazzon, Ph.D. | +39(0)294372686 |
| 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 | |
| Principal Investigator: | Nicola Fazio, M.D., Ph.D. | European Institute of Oncology, IEO, IRCCS |
Documents provided by European Institute of Oncology:
| 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: | August 13, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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NEN NET NEC |
COVID-19 SARS-CoV-2 Coronavirus |
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COVID-19 Neuroendocrine Tumors Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |