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

NCT ID: NCT04768153

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2023-09-25

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Serology

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Center of Martinique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Martinique

Fort-de-France, , Martinique

Site Status

Countries

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Martinique

Other Identifiers

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20_RIPH3_04

Identifier Type: -

Identifier Source: org_study_id

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