Clinical trial NCT04686747: COVID - 19 and Advanced Gastro-intestinal Cancer Treatment
Official title: COVID - 19 and Advanced Gastro-intestinal Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Gastric Cancer
Esophagus Cancer
Colorectal Cancer
Lead sponsor: S.M. Misericordia Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. In the study are included both patients treated with a curative or palliative intent.

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.

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.

Primary outcomes:
measure: Rate of advanced Esophageal, Gastric, Pancreatic and Colorectal cancer in 2020 compared to 2019.
timeFrame: From January 2019 to December 2020
Secondary outcomes:
measure: Rate of neo-adjuvant therapy in 2020 compared to 2019
timeFrame: From January 2019 to December 2020
measure: Rate of palliative procedure in 2020 compared to 2019
timeFrame: From January 2019 to December 2020
measure: Rate of preoperative chemo or radiotherapy in 2020 compared to 2019 for metastatic disease.
timeFrame: From January 2019 to December 2020
measure: Rate of patient unable to performer adjuvant treatment in 2020 compared to 2019
timeFrame: From January 2019 to December 2020
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD
state: Tuscany
Study officials:
References: