Screening of Cancer Patients to Assess Impact of COVID-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2022-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking

NCT04408339

Cancer COVID

UNKNOWN

Immunological Responses of COVID-19 Vaccination

NCT05238467

Cancer; Chemotherapy

COMPLETED

Lopinavir/Ritonavir for the Treatment of COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year

NCT04455958

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed

WITHDRAWN PHASE2

Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study

NCT04445870

Cancer

COMPLETED

To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment

NCT04821570

Breast Cancer Lung Cancer Melanoma (Skin)

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid-19 Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasopharyngeal (NP) swabs

NP swabs:

* At the time of consent
* 3-6 weeks after starting cancer treatment (for patients whose treatment has yet not started) or 3-6 weeks after first swab (for patients already on treatment)
* 3 months after second swab
* 6 months after second swab
* 12 months after second swab

Nasopharyngeal (NP) swab

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No