Registry on NEN Patients and COVID-19

NCT04444401 | Unknown

• 1 other identifier: IEO-1291
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors; COVID-19

Keywords

NEN; NET; NEC; COVID-19; SARS-CoV-2; Coronavirus

Outcome Measures

Primary Outcomes (2)

• Correlation between clinical parameters and SARS-CoV-2 infection

  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

  To evaluate the impact of SARS-CoV-2 Infection in NEN patients

  01/2020 - 12/2020

Secondary Outcomes (2)

• major demographic features

  01/2020 - 12/2020

• type of NEN

  01/2020 - 12/2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a NEN of any type with a positive SARS-CoV-2 swab (RT-PCR).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology, IEO, IRCCS

Milan, MI, 20141, Italy

RECRUITING

Related Publications (4)

• Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

  PMID: 31978945 BACKGROUND

• Yu J, Ouyang W, Chua MLK, Xie C. SARS-CoV-2 Transmission in Patients With Cancer at a Tertiary Care Hospital in Wuhan, China. JAMA Oncol. 2020 Jul 1;6(7):1108-1110. doi: 10.1001/jamaoncol.2020.0980.

  PMID: 32211820 BACKGROUND

• Al-Shamsi HO, Alhazzani W, Alhuraiji A, Coomes EA, Chemaly RF, Almuhanna M, Wolff RA, Ibrahim NK, Chua MLK, Hotte SJ, Meyers BM, Elfiki T, Curigliano G, Eng C, Grothey A, Xie C. A Practical Approach to the Management of Cancer Patients During the Novel Coronavirus Disease 2019 (COVID-19) Pandemic: An International Collaborative Group. Oncologist. 2020 Jun;25(6):e936-e945. doi: 10.1634/theoncologist.2020-0213. Epub 2020 Apr 27.

  PMID: 32243668 BACKGROUND

• Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.

  PMID: 32066541 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nicola Fazio, M.D., Ph.D.

  European Institute of Oncology, IEO, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darina Tamayo, PharmSc

CONTACT

+39(0)294372686; darina.tamayo@ieo.it

Cristina Mazzon, Ph.D.

CONTACT

+39(0)294372686

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 23, 2020
• Study Start: June 15, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

IT (1)