Pancreatic CancerPanCOVIDNCT04380766
Covid-19 Pandemic and Pancreatic Surgery in Italy
An observational study of Pancreatic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer
- Type of treatment
- Surgery or procedure
- How many people
- 730 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 31 Jul 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diagnosis of pancreatic cancer
Who may be able to join
- all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods
Who cannot join
- patients under the age of 18
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
Rome, Lazio, 00168
About this study
Official title: Effects of Covid-19 Pandemic on Pancreatic Surgery in Italy. A Multicenter Observational Clinical Study
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer
- Keywords
- Pancreatic cancer, Pancreatic surgery, COVID-19
- Medical subject headings
- Pancreatic Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancerProcedure or surgery
Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes
| Study group | Role | What they receive |
|---|---|---|
| Pre-COVID | All patients with pancreatic cancer diagnosis before COVID-19 pandemic Receives: 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 Receives: Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pancreatic cancer management during the COVID-19 pandemic
Measured: From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Jan 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 730 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Alfieri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380766
- Sponsor's protocol ID
- FPGemelliIRCCS
- Acronym
- PanCOVID
- Status last verified
- Jul 2020
- First submitted
- 21 Apr 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34817837
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Covid-19 Pandemic on Pancreatic Surgery in Italy. A Multicenter Observational Clinical Study
- ClinicalTrials.gov ID
- NCT04380766
- Acronym / sponsor ID
- PanCOVID / FPGemelliIRCCS
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Pancreatic surgery, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-COVID | – | Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancerAll patients with pancreatic cancer diagnosis before COVID-19 pandemic |
| COVID | – | Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancerAll patients with pancreatic cancer diagnosis during COVID-19 pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diagnosis of pancreatic cancer
Key inclusion criteria (1 listed)
- all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods
Key exclusion criteria (2 listed)
- patients under the age of 18
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancerComparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes | Procedure or surgery | COVID, Pre-COVID |
Primary outcome
Changes in pancreatic cancer management during the COVID-19 pandemic
Time frame: From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 34817837Quero 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pancreatic cancer management during the COVID-19 pandemic (time frame: From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.