COVID - 19 and Advanced Gastro-intestinal Cancer Treatment

NCT ID: NCT04686747

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-06-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Esophageal Cancer

No interventions assigned to this group

Gastric Cancer

No interventions assigned to this group

Pancreatic Cancer

No interventions assigned to this group

Colorectal Cancer

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients submitted to elective surgery for esophageal, gastric, pancreatic and colorectal cancer in the year 2019-2020;
• Patients submitted to emergency surgery/procedure (Interventional radiology, endoscopic procedure) for complication (i.e. perforation, bleeding, occlusion) secondary to esophageal, gastric, pancreatic and colorectal cancer in the year 2019-2020;
• Patients submitted to palliative surgery/procedure (i.e. stoma, GEA, external biliary drainage, feeding jejunostomy) for esophageal, gastric, pancreatic and colorectal cancer in the year 2019-2020;
• Patients undergoing preoperative chemo or radiation therapy for locally advanced or metastatic esophageal, gastric, pancreatic and colorectal cancer in the year 2019-2020;
• Patients undergoing to adjuvant therapy after esophageal, gastric, pancreatic and colorectal cancer I surgery in the year 2019-2020

Exclusion Criteria

• Patients under 18 years old and over 85 years old;
• Patients with multiple tumors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S.M. Misericordia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Giuliani Giuseppe

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD

Grosseto, Tuscany, Italy

Countries

Italy

References

Giuliani G, Coletta D, Guerra F, Esposito S, Esposito A, De Pastena M, Rega D, Delrio P, La Raja C, Spinelli A, Massaron S, De Nardi P, Kauffmann EF, Boggi U, Deidda S, Zorcolo L, Marano A, Borghi F, Piccoli M, Depalma N, D'Ugo S, Spampinato M, Cozzani F, Del Rio P, Marcellinaro R, Carlini M, De Rosa R, Scabini S, Maiello F, Polastri R, Turri G, Pedrazzani C, Zese M, Parini D, Coratti A; MIS-COVID-AGICT Collaborative Group. The MIS-COVID-AGICT Study: Trend of Minimally Invasive Surgery for Gastrointestinal Cancer Treatment During the First Waves of the COVID-19 Pandemic in Italy. Subgroup Analysis from the COVID-AGICT Study: COVID-19 and Advanced Gastrointestinal Cancer Surgical Treatment. J Laparoendosc Adv Surg Tech A. 2023 Jun;33(6):579-585. doi: 10.1089/lap.2023.0058. Epub 2023 May 2.

Reference Type: DERIVED

PMID: 37130329 (View on PubMed)

Other Identifiers

MH - COVID - AGICT

Identifier Type: -

Identifier Source: org_study_id