COVID-19 and Cancer Patients (OnCovid)
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|ClinicalTrials.gov Identifier: NCT04393974|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : July 15, 2022
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|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||OnCovid: Natural History and Outcomes of Cancer Patients During the COVID19 Epidemic|
|Actual Study Start Date :||March 24, 2020|
|Estimated Primary Completion Date :||March 24, 2023|
|Estimated Study Completion Date :||March 24, 2024|
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.
- Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer [ Time Frame: 2 years ]Compiling a list of symptoms experienced by patients recruited onto the trial
- Assessing what factors are involved in prognosis of cancer patients with COVID-19 [ Time Frame: 2 years ]Evaluate prognostic factors for survival in patients with SARS-CoV-2 infection and cancer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
The investigators will evaluate and include consecutive patients observed in the outpatients and inpatients facility of the study centre meeting all the following CRITERIA:
- Be ≥18 years of age.
- Have a confirmed diagnosis of malignancy of any type.
- Have a confirmed diagnosis of SARS-CoV-2 infection.
Patients will not be entered in the study database when one or more of the following CRITERIA are present:
- Unconfirmed diagnosis of SARS-CoV-2 infection
- Insufficient clinical/follow up data.
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): NCT04393974
|Contact: David J Pinato, MD||+44 (0) 207 594 email@example.com|
|Imperial College Healthcare NHS Trust||Recruiting|
|London, United Kingdom, W12 0HS|
|Contact: David J Pinato, MD firstname.lastname@example.org|
|Principal Investigator: David J Pinato, MD|
|Principal Investigator:||David J Pinato, MD||Clinical Senior Lecturer and Consultant in Medical Oncology|
|Responsible Party:||Imperial College London|
|Other Study ID Numbers:||
|First Posted:||May 19, 2020 Key Record Dates|
|Last Update Posted:||July 15, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|