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Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies (RESILIENCE)

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: NCT04768153
Recruitment Status : Active, not recruiting
First Posted : February 24, 2021
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Study Description
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Brief Summary:

The public health council (Haut Conseil de Santé Publique) published a statement on 14 March 2020 relating to the management of patients with severe forms of COVID-19, stipulating specific recommendations for patients with cancer.

The statement notes that patients with cancer at much higher risk (four to five times higher) of several respiratory complications, which develop very rapidly, especially if they had recently undergone surgery or chemotherapy in the previous few weeks, and that this risk could be life-threatening, on top of the cancer-related risk. In addition, the statement noted that:

  • COVID-19 appears to be more frequent in patients with cancer than among the general population (1% vs 0.29%)
  • Among those infected, the risk of severe respiratory complications requiring admission to the intensive care unit (ICU) is higher in patients with cancer than among those without (39% vs 8%, P=0.0003).
  • A history of chemotherapy or surgery in the previous months is an important prognostic factor for the development of severe respiratory complications (odds ratio (OR) = 5.34, P= 0.0026).
  • Deterioration of respiratory function occurs more quickly in patients with cancer (13 vs 43 days, hazard ratio (HR) 3.56, 95% confidence interval (CI) [1.65-7.69]).

In addition, COVID-19 may lead to a change in the diagnostic and therapeutic management of patients with cancer, with potential consequences such as use of oral treatments at home, discontinuation of anticancer therapy depending on the context, or prioritization of management according to curative/palliative treatment type, age, and line of therapy.

International studies previously reported the psychological repercussions of major epidemics on the emotional state. The impact of COVID-19 on patients with cancer therefore warrants evaluation, among cancer patients in the French West Indies, in the current situation of nationwide lockdown.


Condition or disease Intervention/treatment
Cancer Biological: Serology

Study Design
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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies: Monitoring Psychological Impact to Optimize Healthcare Delivery Strategies in Unique Public Health Circumstances
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients Biological: Serology
Serological diagnosis of COVID-19 in patients with cancer from a sample of cancer patients, at 3 and 6 months after implementation of confinement in France


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Psychiatric disorders [ Time Frame: 3 months after implementation of confinement in France ]
    Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic

  2. Evaluation of Psychiatric disorders [ Time Frame: 6 months after implementation of confinement in France ]
    Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic


Biospecimen Retention:   Samples With DNA
Realization of the COVID -19 serological profile of cancer patients

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cancer patients followed at the Martinique University Hospital
Criteria

Inclusion Criteria:

  • Patients aged 18 years or older living in the French West Indies
  • Patient with prevalent cancer of the prostate, breast, lung, colon or rectum
  • Patients who receive the information leaflet and do not express any opposition to the use of their personal medical data

Exclusion Criteria:

  • Patients who are unable to answer the study questionnaires
  • Patients who do not speak fluent French
  • Persons under legal protection
Contacts and Locations
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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): NCT04768153


Locations
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Martinique
CHU Martinique
Fort-de-France, Martinique, 97261
Sponsors and Collaborators
University Hospital Center of Martinique
More Information
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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT04768153    
Other Study ID Numbers: 20_RIPH3_04
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University Hospital Center of Martinique:
Psychiatry
Public health