NCT04406571

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

May 27, 2020

Last Update Submit

January 23, 2024

Conditions

Keywords

pancreatic adenocarcinomapatient managementhealthcare system reorganizationSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Pancreatic adenocarcinoma treatment

    curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care

    6 months

Study Arms (2)

"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.

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.

Other: Data record

Interventions

Data record

"pancreatic adenocarcinoma after COVID-19 containment " group"pancreatic adenocarcinoma before COVID-19 containment " group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pancreatic adenocarcinoma diagnosed between 01/09/2019 and 31/10/2020.

You may qualify if:

  • 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.

You may not qualify if:

  • with neuroendocrine neoplasia
  • for whom histology showed non pancreatic
  • with cystadenoma or IPMN without invasive adenocarcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Electronic Health Records

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 28, 2020

Study Start

April 1, 2020

Primary Completion

December 31, 2021

Study Completion

May 31, 2022

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations