Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection (ONCOVID-19)
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| ClinicalTrials.gov Identifier: NCT04363632 |
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Recruitment Status :
Completed
First Posted : April 27, 2020
Last Update Posted : July 1, 2020
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| Condition or disease |
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| Sars-CoV2 Cancer |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 1231 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 1 Month |
| Official Title: | Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection |
| Actual Study Start Date : | April 2, 2020 |
| Actual Primary Completion Date : | June 30, 2020 |
| Actual Study Completion Date : | June 30, 2020 |
- 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).
- 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.
- 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)
- 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
- Complications [ Time Frame: 28 days after the date of the diagnostic procedure ]Associated complications described by their type
- Hospitalizations [ Time Frame: 28 days after the date of the diagnostic procedure ]proportion of hospitalizations
- Patients' characteristics [ Time Frame: At the date of the diagnostic procedure ]To describe accurately patients' characteristics in terms of demographics
- Patients' characteristics [ Time Frame: At the date of the diagnostic procedure ]To describe accurately patients' characteristics in type of tumor
- Patients' characteristics [ Time Frame: At the date of the diagnostic procedure ]To describe accurately patients' characteristics in type of anticancer treatment,
- Patients' characteristics [ Time Frame: At the date of the diagnostic procedure ]To describe accurately patients' characteristics in terms of comorbidities
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363632
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| Responsible Party: | Centre Leon Berard |
| ClinicalTrials.gov Identifier: | NCT04363632 |
| Other Study ID Numbers: |
ET20-069 |
| First Posted: | April 27, 2020 Key Record Dates |
| Last Update Posted: | July 1, 2020 |
| Last Verified: | June 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Oncology Epidemiology Predictive factors |
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COVID-19 Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |