Global data collection on neuroendocrine tumor patients with COVID-19
InterNaTional rEgistry oN Sars-cov-2posItiVe nEuroendocrine Neoplasm Patients (INTENSIVE)
European Institute of Oncology · NCT04444401
This study is collecting information from patients with neuroendocrine tumors who have had COVID-19 to see how the virus affects their health and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology (other) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT04444401 on ClinicalTrials.gov |
What this trial studies
This study aims to create an international database to collect and analyze data on patients with neuroendocrine tumors (NEN) who have tested positive for SARS-CoV-2. It will gather both retrospective and prospective data to understand the frequency of COVID-19 events, clinical management, and outcomes among NEN patients. The study addresses the challenges of scattered data and aims to provide a comprehensive overview of how COVID-19 affects this specific patient population. By consolidating information from various sources, the study seeks to establish reliable clinical recommendations for managing NEN patients during the pandemic.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with any type of neuroendocrine tumor who have tested positive for SARS-CoV-2.
Not a fit: Patients with small cell lung cancer or non-pure neuroendocrine neoplasms will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights that improve the clinical management and outcomes of NEN patients infected with COVID-19.
How similar studies have performed: While there have been studies on cancer patients and COVID-19, this specific approach focusing on neuroendocrine tumors is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Milan, MI
- European Institute of Oncology, IEO, IRCCS — Milan, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Nicola Fazio, M.D., Ph.D. — European Institute of Oncology, IEO, IRCCS
- Study coordinator: Darina Tamayo, PharmSc
- Email: darina.tamayo@ieo.it
- Phone: +39(0)294372686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroendocrine Tumors, COVID-19, NEN, NET, NEC, SARS-CoV-2, Coronavirus