OnCovid: COVID-19 and Cancer Patients

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04393974
Collaborator
(none)
1,000
Enrollment
1
Location
48
Anticipated Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Routinely collected data will be used to assess the morbidity and mortality of cancer patients following a positive COVID-19 infection.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    The SARS-CoV-2, (COVID-19) virus of the coronavirus family is believed to have been transmitted from animal to human. On 12th March 2020, the World Health Organisation (WHO) declared this particular coronavirus outbreak a pandemic.

    How COVID-19 affects people is still not widely understood. Some people who have tested positive for the virus have been asymptomatic while others, who were otherwise well and healthy before infection, have died. Currently, information obtained so far suggests that most COVID-19 illness, however older people and people with severe comorbidities such as heart and lung disease and diabetes, seem to be at higher risk of developing serious COVID-19 illness.

    This research is a retrospective, non-interventional study whose aim is to describe the features of COVID-19 infection specifically in cancer patients; to investigate its severity in this particular population and evaluate the long-term outcomes by means of medical charts review of consecutive patients co-diagnosed with SARS-CoV-2 infection and malignancy.

    Patients will be identified from electronic medical records and entered into a pre-designed database. All information used will have been previously collected as part of routine standard of care and will involve but is not limited to: blood test results, prior and current anti-cancer therapy, medical history and most importantly clinical outcomes, such as response to any treatment provided for COVID-19 and patients' survival in relation to baseline clinic-pathologic profile. All data will be collected by each patient's team and will be anonymised and stored in a password-protected NHS computer.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    OnCovid: Natural History and Outcomes of Cancer Patients During the COVID19 Epidemic
    Actual Study Start Date :
    Mar 24, 2020
    Anticipated Primary Completion Date :
    Mar 24, 2022
    Anticipated Study Completion Date :
    Mar 24, 2024

    Arms and Interventions

    ArmIntervention/Treatment
    Cancer patients with COVID-19

    All cancer patients can be recruited onto this research following a positive test for Sars-Cov2. The research will follow what treatments they are given for the infection, but also look at their past medical history including prior and any current anti-cancer therapy.

    Outcome Measures

    Primary Outcome Measures

    1. Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer [2 years]

      Compiling a list of symptoms experienced by patients recruited onto the trial

    2. Assessing what factors are involved in prognosis of cancer patients with COVID-19 [2 years]

      Evaluate prognostic factors for survival in patients with SARS-CoV-2 infection and cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    The investigators will evaluate and include consecutive patients observed in the outpatients and inpatients facility of the study centre meeting all the following CRITERIA:

    1. Be ≥18 years of age.

    2. Have a confirmed diagnosis of malignancy of any type.

    3. Have a confirmed diagnosis of SARS-CoV-2 infection.

    Exclusion Criteria:

    Patients will not be entered in the study database when one or more of the following

    CRITERIA are present:
    1. Unconfirmed diagnosis of SARS-CoV-2 infection

    2. Insufficient clinical/follow up data.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Imperial College Healthcare NHS TrustLondonUnited KingdomW12 0HS

    Sponsors and Collaborators

    • Imperial College London

    Investigators

    • Principal Investigator: David J Pinato, MD, Clinical Senior Lecturer and Consultant in Medical Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT04393974
    Other Study ID Numbers:
    • 282140
    First Posted:
    May 19, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 9, 2022