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NCT Number: NCT04386512

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

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.

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Key information

Conditions

COVID Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH de Versailles

Le Chesnay, France

About this study

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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Who can participate

Healthy volunteers accepted: No

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

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

-

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 2 months

  2. transfer to ICU

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study title

Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique

Acronym: LymphoCov1

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
Aug 7, 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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