- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697927
A Study of Risk Factors for the COVID-19 Virus Infection
January 7, 2026 updated by: Memorial Sloan Kettering Cancer Center
Ascertainment of Epidemiologic Risk Information to Assess Susceptibility to and Severity of SARS-CoV-2 Infection
The purpose of this study is to collect information that will help the reasearchers learn more about COVID-19 infections in cancer patients, and to find out about the effects of these infections on cancer treatment and outcomes.
The research study involves asking people to complete a series of online questionnaires that include questions about their medical history, lifestyle, and risk factors related to the COVID-19 infection.
The study will enroll both MSK patients and their household family members.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
389
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
As this is an institution-wide registry, potential research subjects will be identified by the Health Informatics group.
Description
Inclusion Criteria:
MSK Patients
- All individuals who have had at least one point of contact since January 1st 2019 as a patient, including visiting an MSK facility for treatment, clinical evaluation, follow-up or screening, COVID-related screening, or a telehealth visit. Household Members of MSK Patients
- Individuals aged 18 or older
- Currently reside in the same household of MSK patients enrolled onto this protocol
- Have an email account
Exclusion Criteria:
- Impaired decision-making capacity as noted in EHR
- Current MSK employee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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MSK Patients
Patients include those undergoing cancer screening and treatment as well as cancer survivors that received COVID-related care.
Both adult and pediatric patients will be included.
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The epidemiologic questionnaires used in this study are a composite of validated questions from multiple sources.
Many of the questions are an expansion of the MSK General Medical Health clinical questionnaire.
Validated questions capturing demographics, employment, risk behaviors, family history, as well as, specific research domains including psychosocial, food security, and financial toxicity have already been utilized in other MSK minimal risk studies.
The COVID-19 symptom and history tracker questions were largely drawn from the COronavirus Pandemic Epidemiology (COPE) consortium study.
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|
Household Members (identified by MSK Patient)
Individuals over the age of 18 (i.e., individuals currently living in the same household as the MSK enrollee).
|
The epidemiologic questionnaires used in this study are a composite of validated questions from multiple sources.
Many of the questions are an expansion of the MSK General Medical Health clinical questionnaire.
Validated questions capturing demographics, employment, risk behaviors, family history, as well as, specific research domains including psychosocial, food security, and financial toxicity have already been utilized in other MSK minimal risk studies.
The COVID-19 symptom and history tracker questions were largely drawn from the COronavirus Pandemic Epidemiology (COPE) consortium study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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develop a comprehensive registry database
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonine Bernstein, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 20-418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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