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Completed

NCT Number: NCT04437719

Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group for a Period of 6 Months During the COVID-19 Pandemic

This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

About this study

Prior to conducting any of the screening tests, the Investigator or his designee will explain the trial fully to the prospective patient and provide him with a copy of the Patient Information Leaflet/Informed Consent Form.

If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file.

The screening questionnaire will be completed. The patient's suitability for the trial will be confirmed by the inclusion/exclusion criteria .

Following completion of the Baseline Questionnaire, patients will receive the Daily Questionnaire. This is designed to assess if they have developed symptoms associated with COVID-19 infection.

If a participant responds that they are not feeling well, a series of follow-up questions will be asked regarding what symptoms they are currently experiencing.

The Daily Questionnaire will be asked of patients every day throughout the Observation Period of 6 months.

At the end of the Observation Period, all patients will complete a series of questionnaires relating to the conduct of the study and tools employed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient over 18 years of age
  • Patient followed in the medical oncology department of Paris Saint-Joseph Hospital Paris in France
  • Patient Having regular access to smartphone and internet sufficient to support study demands
  • French-speaking patient
  • Affiliation to the social security network
  • Willing and able to provide given oral, free, informed and express consent

Exclusion criteria

  • Patients unable or unwilling to perform all requested study tasks
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Pregnant or lactating patient

Treatment and study plan

Obvio-19 app

Other

As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.

Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.

To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.

To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.

Primary outcomes

  1. COVID-19 infection's symptoms

    Time frame: Observational period of 6 months

    Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.

Secondary outcomes

  1. Incidence and course of symptoms of COVID-19 infection

    Time frame: During a period of 6 months

    To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.

  2. Correlation of the COVID-19 infection with the biological and clinical data of patients

    Time frame: After a period of 6 months

    To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Collaborators

  • ObvioHealth

Registry information

Official study title

Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020

Acronym: OBVIONCO

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Jun 30, 2022

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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