Pancreatic CancerCOVID - AGICTNCT04686747
COVID - 19 and Advanced Gastro-intestinal Cancer Treatment
An observational study of Pancreatic Cancer and Gastric Cancer, run by S.M. Misericordia Hospital at 1 site in Italy.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Gastric Cancer, Esophagus Cancer
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 30 Jun 2021
- 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 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients under 18 years old and over 85 years old;
- Patients with multiple tumors.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD
Grosseto, Tuscany, 58100
About this study
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?
Read the detailed description
- 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.
- 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
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Cancer | Not described | |
| Gastric Cancer | Not described | |
| Pancreatic Cancer | Not described | |
| Colorectal Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From January 2019 to December 2020
Secondary outcomes (4)
Rate of neo-adjuvant therapy in 2020 compared to 2019
To show any difference in the rate of cancer related neo-adjuvant therapy in 2020 compared to 2019;
Measured: From January 2019 to December 2020
Rate of palliative procedure in 2020 compared to 2019
To show any difference in the rate of cancer related palliative procedures/ bridge therapy in 2020 compared to 2019, before starting with standard treatment;
Measured: From January 2019 to December 2020
Rate of preoperative chemo or radiotherapy in 2020 compared to 2019 for metastatic disease.
To show any difference of patients unable to performer cancer related preoperative chemo or radiotherapy in 2020 compared to 2019 due to scarce performance status or for symptomatic disease;
Measured: From January 2019 to December 2020
Rate of patient unable to performer adjuvant treatment in 2020 compared to 2019
Rate of patients unable to performer cancer related adjuvant therapy in 2020 compared to 2019 due to scarce performance status
Measured: From January 2019 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2021
- Study completion30 Jun 2021
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.M. Misericordia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuliani Giuseppe, Ospedale della Misericordia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686747
- Sponsor's protocol ID
- MH - COVID - AGICT
- Acronym
- COVID - AGICT
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37130329
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID - 19 and Advanced Gastro-intestinal Cancer Treatment
- ClinicalTrials.gov ID
- NCT04686747
- Acronym / sponsor ID
- COVID - AGICT / MH - COVID - AGICT
- Conditions
- Pancreatic Cancer, Gastric Cancer, Esophagus Cancer, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- S.M. Misericordia HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Dec 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.
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
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Esophageal Cancer | – | – |
| Gastric Cancer | – | – |
| Pancreatic Cancer | – | – |
| Colorectal Cancer | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under 18 years old and over 85 years old;
- Patients with multiple tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of advanced Esophageal, Gastric, Pancreatic and Colorectal cancer in 2020 compared to 2019.
Time frame: From January 2019 to December 2020
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.
4 secondary outcomes
Rate of neo-adjuvant therapy in 2020 compared to 2019
Time frame: From January 2019 to December 2020
Rate of palliative procedure in 2020 compared to 2019
Time frame: From January 2019 to December 2020
Rate of preoperative chemo or radiotherapy in 2020 compared to 2019 for metastatic disease.
Time frame: From January 2019 to December 2020
Rate of patient unable to performer adjuvant treatment in 2020 compared to 2019
Time frame: From January 2019 to December 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 Jan 2024.
- Derived from this study: PubMed 37130329Giuliani 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.
- Individual participant dataSharing planned: No
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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 and Gastric Cancer, run by S.M. Misericordia Hospital 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 5 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 Jan 2024. 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?
Rate of advanced Esophageal, Gastric, Pancreatic and Colorectal cancer in 2020 compared to 2019. (time frame: From January 2019 to December 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 NCT04686747, 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 Jan 2024.