NCT04616950

Brief Summary

The hospital care of patients with cancerous pathology is part of a multidisciplinary care path that includes many stages. The treatment conditions in this course vary depending on the reasons that led to suspect the existence of a cancerous pathology: accidental discovery, screening, warning signs (sometimes expressed in an acute form) or referral for treatment in charge after the diagnosis has already been made. As soon as the patient presents to the hospital, various expertises are mobilized to establish the diagnosis, carry out the extension assessment and assess the comorbidities and conditions that may have an impact on the choice of treatments. During this initial evaluation, each file is evaluated in a Multidisciplinary Consultation Meeting to define the optimal therapeutic strategy which will often include several stages involving surgery, radiotherapy, medical oncology (chemotherapy, immunotherapy, targeted therapy, etc. hormone therapy), interventional radiology, and / or supportive oncological care (nutrition, pain treatment, correction of metabolic abnormalities, palliative care, etc.). This treatment path is considered to be very complex and the fluidity of its organization determines the processing times. The management of patients in a cancer department may vary depending on the organization specific to each hospital. The health crisis induced by the COVID-19 epidemic, associated with the containment measures put in place from March 19 to May 11, 2020, have limited the use of patients in hospitals, even for emergency activities. It has also led to a reorganization of scheduled activities within establishments, with a concentration of resources around unscheduled care, in particular COVID patients. In many establishments, the other activities were, for many, deprogrammed with postponed appointments. The impact of this epidemic on the hospital journey of patients with cancerous pathology is the subject of questions at the national level. The delays in diagnosis and treatment induced have possibly had an impact on the quality of the care and on the delays with, as a corollary, a possible loss of opportunity for the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

First Submitted

Initial submission to the registry

November 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

November 4, 2020

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital course of patients with cancer of the digestive system

    This outcome corresponds to the basis of the delay, measured as a continuous quantitative variable, in number of days between entry into the course and the first inpatient treatment in the medical oncology department.

    Day 1

Secondary Outcomes (1)

  • Modeling of the hospital journey based on observations made during the period preceding the COVID-19 epidemic

    Day 1

Eligibility Criteria

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

Patients with primary cancer of the digestive system: cancer of the esophagus, stomach, small intestine, colon, rectosigmoid junction, rectum, anal canal, liver , gall bladder, bile ducts and pancreas; were hospitalized for the first time in the oncology department within the Paris Saint Joseph Hospital Group, between January 1, 2019 and October 31, 2020.

You may qualify if:

  • Patients aged ≥ 18 years
  • Patients with primary cancer of the digestive system: cancer of the esophagus, stomach, small intestine, colon, rectosigmoid junction, rectum, anal canal, liver , gall bladder, bile ducts and pancreas;
  • Patients hospitalized for the first time in the medical oncology department in full hospitalization, week or day;
  • Patients hospitalized between January 1, 2019 and October 31, 2020
  • French-speaking patient

You may not qualify if:

  • Patients with secondary cancer or a relapse of cancer of the digestive system
  • Patients who do not require hospitalization in medical oncology
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient objecting to the use of their medical data in the context of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

Location

Related Publications (5)

  • Belle A, Barret M, Bernardini D, Tarrerias AL, Bories E, Costil V, Denis B, Gincul R, Karsenti D, Koch S, Laquiere A, Lecomte T, Quentin V, Rahmi G, Robaszkiewicz M, Vaillant E, Vanbiervliet G, Vienne A, Dumeiran F, Gronier O, Chaussade S; French Society of Digestive Endoscopy (Societe Francaise d'Endoscopie Digestive). Impact of the COVID-19 pandemic on gastrointestinal endoscopy activity in France. Endoscopy. 2020 Dec;52(12):1111-1115. doi: 10.1055/a-1201-9618. Epub 2020 Jul 8.

  • Soreide K, Hallet J, Matthews JB, Schnitzbauer AA, Line PD, Lai PBS, Otero J, Callegaro D, Warner SG, Baxter NN, Teh CSC, Ng-Kamstra J, Meara JG, Hagander L, Lorenzon L. Immediate and long-term impact of the COVID-19 pandemic on delivery of surgical services. Br J Surg. 2020 Sep;107(10):1250-1261. doi: 10.1002/bjs.11670. Epub 2020 Apr 30.

  • Grosclaude P, Azria D, Guimbaud R, Thibault S, Daubisse-Marliac L, Cartron G, Renaudie MJ, Dalbies PA, Delord JP, Bauvin E. [COVID-19 impact on the cancer care structuration: Example of the multidisciplinary team meeting dedicated to oncology in Occitanie]. Bull Cancer. 2020 Jul-Aug;107(7-8):730-737. doi: 10.1016/j.bulcan.2020.05.001. Epub 2020 May 18. French.

  • Sud A, Jones ME, Broggio J, Loveday C, Torr B, Garrett A, Nicol DL, Jhanji S, Boyce SA, Gronthoud F, Ward P, Handy JM, Yousaf N, Larkin J, Suh YE, Scott S, Pharoah PDP, Swanton C, Abbosh C, Williams M, Lyratzopoulos G, Houlston R, Turnbull C. Collateral damage: the impact on outcomes from cancer surgery of the COVID-19 pandemic. Ann Oncol. 2020 Aug;31(8):1065-1074. doi: 10.1016/j.annonc.2020.05.009. Epub 2020 May 19.

  • Gelman A, Rubin DB. Markov chain Monte Carlo methods in biostatistics. Stat Methods Med Res. 1996 Dec;5(4):339-55. doi: 10.1177/096228029600500402.

MeSH Terms

Conditions

COVID-19Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anne BURONFOSSE, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 5, 2020

Study Start

December 1, 2020

Primary Completion

June 30, 2021

Study Completion

April 26, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations