- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04363632
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)
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Bordeaux, Frankrike
- Institut Bergonie
-
Caen, Frankrike, 14076
- Centre Francois Baclesse
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Chambéry, Frankrike, 73011
- Centre Hospitalier Metropole Savoie
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Clermont-Ferrand, Frankrike, 63011
- Centre Jean Perrin
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Dijon, Frankrike, 21079
- Centre Georges François Leclerc
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Lille, Frankrike, 59020
- Centre Oscar Lambret
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Lyon, Frankrike, 69373
- Centre Léon Bérard
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Metz-Tessy, Frankrike, 74370
- CH Annecy-Genevois
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Montpellier, Frankrike, 34298
- Institut de Cancérologie de Montpellier
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Montélimar, Frankrike, 26216
- Groupement Hospitalier Porte de Provence
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Nice, Frankrike
- Centre Antoine Lacassagne
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Pierre-Bénite, Frankrike, 69495
- Centre Hospitalier Lyon-Sud
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Reims, Frankrike, 51726
- Institut Jean Godinot
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Rouen, Frankrike, 76038
- Centre Henri Becquerel
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Saint-Herblain, Frankrike, 44805
- Institut de Cancérologie de l'Ouest
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Strasbourg, Frankrike, 67033
- Institut de cancérologie Strasbourg Europe (ICANS)
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Toulouse, Frankrike, 31059
- Institut Universitaire du Cancer de Toulouse - IUCT Oncopole
-
Valence, Frankrike
- Ch Valence
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mortality of cancer patients under active anticancer treatment
Tidsramme: 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).
|
28 days after the date of the diagnostic procedure
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall survival
Tidsramme: 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.
|
6 months (i.e. at the the time of last patient last visit)
|
Hospitalizations
Tidsramme: 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)
|
28 days after the date of the diagnostic procedure
|
Death
Tidsramme: 6 months (i.e. at the the time of last patient last visit)
|
Cause of death, related or not to the COVID-19
|
6 months (i.e. at the the time of last patient last visit)
|
Complications
Tidsramme: 28 days after the date of the diagnostic procedure
|
Associated complications described by their type
|
28 days after the date of the diagnostic procedure
|
Hospitalizations
Tidsramme: 28 days after the date of the diagnostic procedure
|
proportion of hospitalizations
|
28 days after the date of the diagnostic procedure
|
Patients' characteristics
Tidsramme: At the date of the diagnostic procedure
|
To describe accurately patients' characteristics in terms of demographics
|
At the date of the diagnostic procedure
|
Patients' characteristics
Tidsramme: At the date of the diagnostic procedure
|
To describe accurately patients' characteristics in type of tumor
|
At the date of the diagnostic procedure
|
Patients' characteristics
Tidsramme: At the date of the diagnostic procedure
|
To describe accurately patients' characteristics in type of anticancer treatment,
|
At the date of the diagnostic procedure
|
Patients' characteristics
Tidsramme: At the date of the diagnostic procedure
|
To describe accurately patients' characteristics in terms of comorbidities
|
At the date of the diagnostic procedure
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ET20-069
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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