Pancreatic AdenocarcinomaCAPANCOVID-19NCT04406571
Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer
An observational study of Pancreatic Adenocarcinoma, run by CHU de Reims at 1 site in France.
Trial summary
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Data record
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 31 May 2022
- 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: Patients with pancreatic adenocarcinoma diagnosed between 01/09/2019 and 31/10/2020.
Who may be able to join
- aged 18 or over,
- with pancreatic adenocarcinoma diagnosed by anatomopathological specimen or without biopsy but with suspicion of pancreatic adenocarcinoma in presence of imaging techniques or Ca19.9 level without evidence for neuroendocrine tumor,
- assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 31/10/2020,
- accepting to participate to the study,
- with or without SARS-CoV-2 infection.
Who cannot join
- with neuroendocrine neoplasia
- for whom histology showed non pancreatic
- with cystadenoma or IPMN without invasive adenocarcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%.
Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.
Read the detailed description
The aim of this study is to study impact of reorganization of the healthcare system during COVID-19 pandemic on pancreatic adenocarcinoma patients management
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Data record
- Keywords
- pancreatic adenocarcinoma, patient management, healthcare system reorganization, SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recordOther
Data record
| Study group | Role | What they receive |
|---|---|---|
| "pancreatic adenocarcinoma before COVID-19 containment " group | patients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 16/03/2020. Receives: Other: Data record | |
| "pancreatic adenocarcinoma after COVID-19 containment " group | patients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 17/03/2020 and 31/10/2020. Receives: Other: Data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic adenocarcinoma treatment
curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 May 2022
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 AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406571
- Sponsor's protocol ID
- PO20042
- Acronym
- CAPANCOVID-19
- Status last verified
- Jan 2024
- First submitted
- 27 May 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brugel M, Letrillart L, Evrard C, Thierry A, Tougeron D, El Amrani M, Piessen G, Truant S, Turpin A, d'Engremont C, Roth G, Hautefeuille V, Regimbeau JM, Williet N, Schwarz L, Di Fiore F, Borg C, Doussot A, Lambert A, Moulin V, Trelohan H, Bolliet M, Topolscki A, Ayav A, Lopez A, Botsen D, Piardi T, Carlier C, Bouche O. Impact of the COVID-19 pandemic on disease stage and treatment for patients with pancreatic adenocarcinoma: A French comprehensive multicentre ambispective observational cohort study (CAPANCOVID). Eur J Cancer. 2022 May;166:8-20. doi: 10.1016/j.ejca.2022.01.040. Epub 2022 Feb 10.
PubMed 35259629
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04406571
- Acronym / sponsor ID
- CAPANCOVID-19 / PO20042
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- pancreatic adenocarcinoma, patient management, healthcare system reorganization, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 28 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 adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%.
Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.
Detailed description
The aim of this study is to study impact of reorganization of the healthcare system during COVID-19 pandemic on pancreatic adenocarcinoma patients management
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "pancreatic adenocarcinoma before COVID-19 containment " group | – | Other: Data recordpatients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 16/03/2020. |
| "pancreatic adenocarcinoma after COVID-19 containment " group | – | Other: Data recordpatients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 17/03/2020 and 31/10/2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic adenocarcinoma diagnosed between 01/09/2019 and 31/10/2020.
Key inclusion criteria (5 listed)
- aged 18 or over,
- with pancreatic adenocarcinoma diagnosed by anatomopathological specimen or without biopsy but with suspicion of pancreatic adenocarcinoma in presence of imaging techniques or Ca19.9 level without evidence for neuroendocrine tumor,
- assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 31/10/2020,
- accepting to participate to the study,
- with or without SARS-CoV-2 infection.
Key exclusion criteria (3 listed)
- with neuroendocrine neoplasia
- for whom histology showed non pancreatic
- with cystadenoma or IPMN without invasive adenocarcinoma
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 |
|---|---|---|
| Data recordData record | Other | "pancreatic adenocarcinoma after COVID-19 containment " group, "pancreatic adenocarcinoma before COVID-19 containment " group |
Primary outcome
Pancreatic adenocarcinoma treatment
Time frame: 6 months
curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care
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 24 Jan 2024.
- Derived from this study: PubMed 35259629Brugel M, Letrillart L, Evrard C, Thierry A, Tougeron D, El Amrani M, Piessen G, Truant S, Turpin A, d'Engremont C, Roth G, Hautefeuille V, Regimbeau JM, Williet N, Schwarz L, Di Fiore F, Borg C, Doussot A, Lambert A, Moulin V, Trelohan H, Bolliet M, Topolscki A, Ayav A, Lopez A, Botsen D, Piardi T, Carlier C, Bouche O. Impact of the COVID-19 pandemic on disease stage and treatment for patients with pancreatic adenocarcinoma: A French comprehensive multicentre ambispective observational cohort study (CAPANCOVID). Eur J Cancer. 2022 May;166:8-20. doi: 10.1016/j.ejca.2022.01.040. Epub 2022 Feb 10.
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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 Adenocarcinoma, run by CHU de Reims at 1 site in France.
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 3 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 24 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 France. 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?
Pancreatic adenocarcinoma treatment (time frame: 6 months). 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 NCT04406571, 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 24 Jan 2024.