Screening of Cancer Patients to Assess Impact of COVID-19

Cancer Clinical Trial

Official title:

A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04373005
• Other study ID #: U-DEPLOY: RESPONSE
• Secondary ID: CAPCR 20-5337
• Status: Terminated
• Start date: May 11, 2020
• Est. completion date: October 6, 2022

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the impact of COVID -19 in the cancer patient population. This will be done by looking at the rate of asymptomatic COVID-19 infection in cancer patients receiving cancer therapy, as well as their immune response.

This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network (UHN) and other centers.

Description:

Given increasing community transmission and the possibility of asymptomatic carriage of virus, it is important to study whether asymptomatic shedders of virus are playing a role in propagating the pandemic. There is currently little data available regarding cancer patients, yet, this population may be particularly susceptible to the COVID-19 infection.

Despite the cancer patient population being at higher risk of COVID-19, no systematic screening has been established and no biomarkers have been identified to determine which patient is at higher risk.

This study will screen patients on active cancer therapy for COVID-19 as a standard of care or a research nasopharyngeal test. Blood samples may also be taken to assess any patient response to the virus and optional saliva samples may also be taken to assess the feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production (eg. secondary to cancer treatments such as radiation, chemotherapy, and/or surgery).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients having an active malignancy who are planned to start therapy within 6 weeks of consent or are receiving a treatment for active malignancy.

• The patient falls under either of the following categories:

1. Asymptomatic for COVID-19 (as per daily screening at the hospital entrance).

2. Has symptoms similar to those of COVID-19 (e.g. fever or flu-like symptoms such as cough or shortness of breath) that are assessed by the overseeing Investigator as being related to disease and unrelated to COVID-19 infection.

Note: Patients who recovered from previous COVID-19 infection will be eligible.

• No contraindication to performing a NP swab and blood work.

Exclusion Criteria:

• Any patients with fever, or flu-like symptoms assessed by the Investigator to be related or potentially related to COVID-19 infection will not be eligible.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 3-4

Related Conditions & MeSH terms

• Cancer
• Covid-19

Intervention

Diagnostic Test:
• Nasopharyngeal (NP) swab
A dry swab will be inserted through one nostril straight towards the back of the nasal passage and rotated gently before the swab is removed.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production		12 months
Other	Compare the evolution of immune and proteomic profile of asymptomatic COVID-19 negative and positive cancer patients		12 months
Primary	Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy		12 months
Secondary	Rate of sero-conversion in cancer patients		12 months
Secondary	Describe the clinical course of COVID-19 infection in cancer patients		12 months