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Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1) (LymphoCov1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386512
Recruitment Status : Completed
First Posted : May 13, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Caroline BESSON, Versailles Hospital

Brief Summary:

The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20).

The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma.

Translated with www.DeepL.com/Translator (free version)


Condition or disease
COVID Lymphoma

Detailed Description:

I

Methods :

  • Multicentric retrospective observational epidemiological study based on the collection of data from patient records.
  • Selection of voluntary hospital sites in regions with excess mortality during the epidemic phase.
  • Systematic identification of Covid-19 cases from coding data (PMSI) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the PMSI.
  • Establishment of an ad hoc CRF for cases only with collection of clinical data concerning lymphoma and Covid-19 and routine biological data: Cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers.
  • Estimated total number of sites: 10-15 and number of cases to be collected: 50-60.

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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. mortality [ Time Frame: 2 months ]
  2. transfer to ICU [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a current or past history of lymphoma who were hospitalized with Covid-19 infection between March the 1st and April the 30th in ile de France or Est region in France
Criteria

Inclusion Criteria:

  • Patients at least 18 years of age with lymphoma and a diagnosis of Covid-19 requiring hospitalization.
  • In order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients.

Exclusion Criteria:

Patients who refused to participate

-


Information from the National Library of Medicine

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): NCT04386512


Locations
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France
CH de Versailles
Le Chesnay, France
Sponsors and Collaborators
Versailles Hospital
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Responsible Party: Caroline BESSON, investigator MD, Versailles Hospital
ClinicalTrials.gov Identifier: NCT04386512    
Other Study ID Numbers: P20/12_LymphoCov
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caroline BESSON, Versailles Hospital:
covid
lymphoma
epidemiology
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases