Registry on NEN Patients and COVID-19

• ClinicalTrials.gov Identifier: NCT04444401
• Recruitment Status: Recruiting
• First Posted: June 23, 2020
• Last Update Posted: August 13, 2021
• Sponsor: European Institute of Oncology
• Information provided by (Responsible Party): European Institute of Oncology

Tracking Information

• First Submitted Date: June 22, 2020
• First Posted Date: June 23, 2020
• Last Update Posted Date: August 13, 2021
• Actual Study Start Date: June 15, 2020
• Estimated Primary Completion Date: December 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 22, 2020)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 22, 2020)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry on NEN Patients and COVID-19
• Official Title: InterNaTional rEgistry oN Sars-cov-2posItiVe nEuroendocrine Neoplasm Patients (INTENSIVE)

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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with a NEN of any type with a positive SARS-CoV-2 swab (RT-PCR).

Condition

• Neuroendocrine Tumors
• COVID-19

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 22, 2020): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2021
• Estimated Primary Completion Date: December 15, 2021 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Darina Tamayo, PharmSc; +39(0)294372686; darina.tamayo@ieo.it

Contact: Cristina Mazzon, Ph.D.; +39(0)294372686

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04444401
• Other Study ID Numbers: IEO-1291
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: European Institute of Oncology
• Original Responsible Party: Same as current
• Current Study Sponsor: European Institute of Oncology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: European Institute of Oncology
• Verification Date: August 2021