NCT04686747

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 26, 2020

Last Update Submit

December 31, 2023

Conditions

Pancreatic CancerGastric CancerEsophagus CancerColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of advanced Esophageal, Gastric, Pancreatic and Colorectal cancer in 2020 compared to 2019.

    The primary endpoint is to show if in Italy the number of cancer mentioned above, was diagnosed in a more advanced stage (i.e. \> I stage, Metastatic disease) in 2020 compared to 2019 as a consequence of COVID-19 pandemic condition.

    From January 2019 to December 2020

Secondary Outcomes (4)

  • Rate of neo-adjuvant therapy in 2020 compared to 2019

    From January 2019 to December 2020

  • Rate of palliative procedure in 2020 compared to 2019

    From January 2019 to December 2020

  • Rate of preoperative chemo or radiotherapy in 2020 compared to 2019 for metastatic disease.

    From January 2019 to December 2020

  • Rate of patient unable to performer adjuvant treatment in 2020 compared to 2019

    From January 2019 to December 2020

Study Arms (4)

Esophageal Cancer

Gastric Cancer

Pancreatic Cancer

Colorectal Cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Grosseto, Tuscany, 58100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 37130329DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsStomach NeoplasmsEsophageal NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 26, 2020

First Posted

December 29, 2020

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

June 30, 2021

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)