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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04406571
Other study ID # PO20042
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date May 31, 2022

Study information

Verified date January 2024
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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%. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date May 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria : 1. aged 18 or over, 2. 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, 3. assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 31/10/2020, 4. accepting to participate to the study, 5. with or without SARS-CoV-2 infection. Exclusion criteria : 1. with neuroendocrine neoplasia 2. for whom histology showed non pancreatic 3. with cystadenoma or IPMN without invasive adenocarcinoma

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data record
Data record

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pancreatic adenocarcinoma treatment curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care 6 months
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