- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406571
Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer (CAPANCOVID-19)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Reims, France
- Damien JOLLY
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria :
- 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.
Exclusion criteria :
- with neuroendocrine neoplasia
- for whom histology showed non pancreatic
- with cystadenoma or IPMN without invasive adenocarcinoma
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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"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.
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Data record
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"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.
|
Data record
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pancreatic adenocarcinoma treatment
Time Frame: 6 months
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curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care
|
6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- COVID-19
- Adenocarcinoma
Other Study ID Numbers
- PO20042
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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