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

NCT04768153 | Terminated

• 1 other identifier: 20_RIPH3_04
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Psychiatry; Public health

Outcome Measures

Primary Outcomes (2)

• Evaluation of Psychiatric disorders

  Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic

  3 months after implementation of confinement in France

• Evaluation of Psychiatric disorders

  Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic

  6 months after implementation of confinement in France

Study Arms (1)

Patients

Biological: Serology

Interventions

Serology 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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients followed at the Martinique University Hospital

You may qualify if:

• 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

You may not qualify if:

• Patients who are unable to answer the study questionnaires
• Patients who do not speak fluent French
• Persons under legal protection

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHU Martinique

Fort-de-France, 97261, Martinique

Location

Biospecimen

Retention: SAMPLES WITH DNA

Realization of the COVID -19 serological profile of cancer patients

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 24, 2021
• Study Start: July 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: September 25, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)