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Sars-CoV2ONCOVID-19NCT04363632

Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection

An observational study of Sars-CoV2 and Cancer, run by Centre Leon Berard at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Sars-CoV2, Cancer
How many people
1,231 participants
Where
18 sitesFrance
Study dates
2 Apr 2020to 30 Jun 2020
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • I1. Confirmed diagnosis of any type of solid or hematologic tumor;
  • I2. Ongoing anticancer treatment (cytotoxic, targeted therapy, immunotherapy or loco regional procedure, including radiotherapy, surgery or interventional radiology procedure) at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) ;
  • 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.

Who cannot join

None listed.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Institut Bergonié

    Bordeaux

  • Centre François Baclesse

    Caen, 14076

  • Centre Hospitalier Métropole Savoie

    Chambéry, 73011

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • CH Annecy-Genevois

    Metz-Tessy, 74370

  • Groupement Hospitalier Porte de Provence

    Montélimar, 26216

  • Institut de Cancérologie de Montpellier

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Institut Jean Godinot

    Reims, 51726

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67033

  • Institut Universitaire du Cancer de Toulouse - IUCT Oncopole

    Toulouse, 31059

  • CH Valence

    Valence

Other trials in France

About this study

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

Conditions
Sars-CoV2, Cancer
Keywords
COVID-19, Oncology, Epidemiology, Predictive factors
Medical subject headings
Neoplasms, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 28 days after the date of the diagnostic procedure

Secondary outcomes (9)

  1. Overall survival

    Overall survival will be defined as the time from the date of the first diagnostic procedure (either diagnostic test or chest imaging) to the date of death due to any cause.

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

  2. Hospitalizations

    The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)

    Measured: 28 days after the date of the diagnostic procedure

  3. Death

    Cause of death, related or not to the COVID-19

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

  4. Complications

    Associated complications described by their type

    Measured: 28 days after the date of the diagnostic procedure

  5. Hospitalizations

    proportion of hospitalizations

    Measured: 28 days after the date of the diagnostic procedure

  6. Patients' characteristics

    To describe accurately patients' characteristics in terms of demographics

    Measured: At the date of the diagnostic procedure

  7. Patients' characteristics

    To describe accurately patients' characteristics in type of tumor

    Measured: At the date of the diagnostic procedure

  8. Patients' characteristics

    To describe accurately patients' characteristics in type of anticancer treatment,

    Measured: At the date of the diagnostic procedure

  9. Patients' characteristics

    To describe accurately patients' characteristics in terms of comorbidities

    Measured: At the date of the diagnostic procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start2 Apr 2020
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,231 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363632
Sponsor's protocol ID
ET20-069
Acronym
ONCOVID-19
Status last verified
Jun 2020
First submitted
23 Apr 2020
Last updated
1 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34135471

Questions about this trial

What is this clinical trial studying?

An observational study of Sars-CoV2 and Cancer, run by Centre Leon Berard at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality of cancer patients under active anticancer treatment (time frame: 28 days after the date of the diagnostic procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04363632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.

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