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

Centre Leon Berard1,231 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,231

Conditions

Sars-CoV2 Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (18)

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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.

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

Hospitalizations

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

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

Death

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

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

Complications

Associated complications described by their type

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

Hospitalizations

proportion of hospitalizations

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

Patients' characteristics

To describe accurately patients' characteristics in terms of demographics

Time frame: At the date of the diagnostic procedure

Data from ClinicalTrials.gov

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