NCT04363632

Brief Summary

National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

18 active sites

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 2, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

April 23, 2020

Last Update Submit

June 30, 2020

Conditions

Keywords

COVID-19OncologyEpidemiologyPredictive factors

Outcome Measures

Primary Outcomes (1)

  • Mortality of cancer patients under active anticancer treatment

    Mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative).

    28 days after the date of the diagnostic procedure

Secondary Outcomes (9)

  • Overall survival

    6 months (i.e. at the the time of last patient last visit)

  • Hospitalizations

    28 days after the date of the diagnostic procedure

  • Death

    6 months (i.e. at the the time of last patient last visit)

  • Complications

    28 days after the date of the diagnostic procedure

  • Hospitalizations

    28 days after the date of the diagnostic procedure

  • +4 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with cancer in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection

You may qualify if:

  • I1. Confirmed diagnosis of any type of solid or hematologic tumor;
  • I3. Patient with suspicion of COVID-19 (clinical symptoms of COVID-19 including fever (\>38°C) and/or respiratory tract symptoms), either confirmed or not.
  • Note 1: Patients must have underwent diagnostic procedures: diagnostic test (positive or negative) and/or chest imaging. Note 2: Patients will be eligible regardless of the presence of a neutropenia (either febrile or not) ;
  • I4. Patient and/or family did not decline data collection after complete information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Institut Bergonié

Bordeaux, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Hospitalier Métropole Savoie

Chambéry, 73011, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CH Annecy-Genevois

Metz-Tessy, 74370, France

Location

Groupement Hospitalier Porte de Provence

Montélimar, 26216, France

Location

Institut de Cancérologie de Montpellier

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51726, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, 67033, France

Location

Institut Universitaire du Cancer de Toulouse - IUCT Oncopole

Toulouse, 31059, France

Location

CH Valence

Valence, France

Location

Related Publications (1)

  • Assaad S, Zrounba P, Cropet C; ONCOVID-19 study Consortium; Blay JY. Mortality of patients with solid and haematological cancers presenting with symptoms of COVID-19 with vs without detectable SARS-COV-2: a French nationwide prospective cohort study. Br J Cancer. 2021 Aug;125(5):658-671. doi: 10.1038/s41416-021-01452-4. Epub 2021 Jun 16.

MeSH Terms

Conditions

NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

April 2, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations