NCT04686747

COVID - 19 and Advanced Gastro-intestinal Cancer Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: S.M. Misericordia Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

A multicenter Italian retrospective study on COVID-19 pandemic condition and advanced Gastro - Intestinal Cancer. Are in Italy increased the new diagnosis of GI cancer in advanced stage in the 2020 compared with 2019, as a consequence of COVID-19?

Detailed description

1. Background The ongoing COVID-19 pandemic condition had a catastrophic consequence on the healthcare system. In order to contain the death from other diseases, such as cancer, the healthcare system still fights a challenging battle focusing the attention on COVD-19 without losing sight of other patient care. Routine screening and non urgent surgeries reduced to increase capacity for COVID-19 patients complications. Moreover, it must take into account the fear for COVID-19 exposure of patients during the routine assessments. Nevertheless, death related to other causes is not decreased. Standard cancer screening is decreased, such as colorectal cancer protocol which dropped by 84.5% through May 20201. As a consequence, according to London JW et al, the incidence of new cancer diagnoses decreased of 65.2%. As matter of fact, the new diagnosis of melanoma dropped by 67.1%, as well as the new diagnosis of lung cancer which dropped of 46.8%1 in April 2020 compared to one year earlier. Furthermore, the number of advanced gastrointestinal cancers are supposed to be increased in the surgical community. As conventional wisdom, the number of patients with locally advanced or metastatic gastrointestinal, as well as patients needing an emergency or a palliative procedure (i.e., stoma, feeding jejunostomy, gastroentero anastomosis) seems increased this year compared to 2019. These therapeutic delays may influence the long-term survival of these patients. An increased rate of related death is expected, rising from 15.5% to 16.6% and 4.8% to 5.3 % for colorectal and lung cancer, respectively. This study aims to investigate whether the main gastrointestinal cancers was diagnosed in a more advanced stage in 2020 compared to 2019 as a consequence of Covid-19 pandemic. 2. Methods This is a multicenter retrospective study that will include patients treated for esophageal, gastric, pancreatic and colorectal cancer, from January 2019 to December 2020 in more than 50 Italian centers. All patients will be included in a disease-specific database, which will be sent to each Italian reference center. A minimum of 1.000 patient/year is expected to show a significative difference between the considered years.

Conditions

• Pancreatic Cancer
• Gastric Cancer
• Esophagus Cancer
• Colorectal Cancer

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-03-01
• Completion: 2021-06-30
• First posted: 2020-12-29
• Last updated: 2024-01-03

Locations

1 site across 1 country: Italy