NCT04380766

Brief Summary

Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

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

Study Start

First participant enrolled

January 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

April 21, 2020

Last Update Submit

July 31, 2020

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerPancreatic surgeryCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Changes in pancreatic cancer management during the COVID-19 pandemic

    From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020

Study Arms (2)

Pre-COVID

All patients with pancreatic cancer diagnosis before COVID-19 pandemic

Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer

COVID

All patients with pancreatic cancer diagnosis during COVID-19 pandemic

Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer

Interventions

Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancerPROCEDURE

Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes

COVIDPre-COVID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with diagnosis of pancreatic cancer

You may qualify if:

  • all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods

You may not qualify if:

  • patients under the age of 18
  • inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma

Rome, Lazio, 00168, Italy

Location

Related Publications (1)

  • Quero G, Pecorelli N, Paiella S, Fiorillo C, Petrone MC, Rosa F, Capretti G, Laterza V, Kauffmann E, Nobile S, Butturini G, Ferrari G, Coratti A, Casadei R, Mazzaferro V, Boggi U, Zerbi A, Salvia R, Falconi M, Alfieri S. Quantitative assessment of the impact of COVID-19 pandemic on pancreatic surgery: an Italian multicenter analysis of 1423 cases from 10 tertiary referral centers. Updates Surg. 2022 Feb;74(1):255-266. doi: 10.1007/s13304-021-01171-8. Epub 2021 Nov 24.

    PMID: 34817837DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2020

First Posted

May 8, 2020

Study Start

January 1, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

IT(1)