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. 2022 Jun 2:12:828660.
doi: 10.3389/fonc.2022.828660. eCollection 2022.

Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19. The COMETA Italian Protocol

Nicola Silvestris  1   2 , Valeria Belleudi  3 , Antonio Addis  3 , Fulvia Pimpinelli  4 , Aldo Morrone  4 , Salvatore Sciacchitano  5 , Rita Mancini  5 , Vito Michele Garrisi  1 , Massimo Costantini  6 , Gennaro Ciliberto  7 , Vincenza Frisardi  6 , Giulia Piaggio  7
Affiliations

Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19. The COMETA Italian Protocol

Nicola Silvestris et al. Front Oncol. .

Abstract

The outbreak of the coronavirus 2 disease 2019 (COVID-19) puts an enormous burden on healthcare systems worldwide. This may worsen outcomes in patients with severe chronic diseases such as cancer, autoimmune diseases, and immune deficiencies. In this critical situation, only a few available data exist, which do not allow us to provide practical guides for the treatment of oncological or immunocompromised patients. Therefore, a further step forward is needed, addressing the specific needs and demands of frail patients in the pandemic era. Here we aim to present a protocol of a study approved by an ethical committee named "CO.M.E.TA". CO.M.E.TA protocol is a network project involving six Italian institutions and its goals are: i) to measure and compare the impact of the pandemic on the access of cancer and immunocompromised patients to therapies in three Italian regions; ii) to assess how reorganizational measures put in place in these different institutions have impacted specific metrics of performance; iii) to establish a COVID-19 Biobank of biological samples from SARS-CoV-2 infected patients to be used to study immunological alterations in patients with immune frailty.

Keywords: SARS-CoV-2; blood biobank; cancer screenings; immune response; pandemic; tracking fragile patients.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
(A) Schematic geographical representation of the six sites involved in the protocol. In the blue light, boxes are indicated the names of the involved towns. The names of the involved sites are indicated in the green and black boxes. The green box indicates COVID-19 free sites, and black boxes indicate COVID-19 mixed sites. (B) Organogram of the people involved in the different activities of the study protocol.
Figure 2
Figure 2
Flow chart of the entire project.
Figure 3
Figure 3
Standard electronic case report form, eCRF. (A) Demographic information, type of vaccination, COVID-19 disease history. (B) Information about molecular and serological tests. (C) Data about sample biobanking.
Figure 4
Figure 4
Volumes of incident surgical interventions for breast, colon-rectal, and lung malignant cancer during the pre-COVID19 pandemic and expected trend lines - Lazio Region.
Figure 5
Figure 5
Flow chart of Aim 2.
Figure 6
Figure 6
Flow chart of Aim 3. Strategy of infection assessment and time sampling shared with all participating sites.
See this image and copyright information in PMC

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