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OpenTrials
Completed

NCT Number: NCT04363632

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

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

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Key information

Conditions

Sars-CoV2 COVID-19 Cancer Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Mortality of cancer patients under active anticancer treatment

    Time frame: 28 days after the date of the diagnostic procedure

    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).

Secondary outcomes

  1. Overall survival

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

    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.

  2. Hospitalizations

    Time frame: 28 days after the date of the diagnostic procedure

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

  3. Death

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

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

  4. Complications

    Time frame: 28 days after the date of the diagnostic procedure

    Associated complications described by their type

  5. Hospitalizations

    Time frame: 28 days after the date of the diagnostic procedure

    proportion of hospitalizations

  6. Patients' characteristics

    Time frame: At the date of the diagnostic procedure

    To describe accurately patients' characteristics in terms of demographics

  7. Patients' characteristics

    Time frame: At the date of the diagnostic procedure

    To describe accurately patients' characteristics in type of tumor

  8. Patients' characteristics

    Time frame: At the date of the diagnostic procedure

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

  9. Patients' characteristics

    Time frame: At the date of the diagnostic procedure

    To describe accurately patients' characteristics in terms of comorbidities

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: ONCOVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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