An observational study in COVID-19, Cancer and Nicotine Dependence, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by University of Wisconsin, Madison · Observational
This cohort study will obtain electronic health record (EHR) data (limited data set) from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. Each site will provide data from their health system EHR on a regular basis that includes all patients identified as having COVID-19 at some point in the interval from February 1, 2020, through January 31, 2022.
This cohort study will obtain electronic health record (EHR) data (limited data set) from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. The Cancer Center Cessation Initiative (C3I) is a project launched by the US National Cancer Institute (NCI) to improve the rate at which NCI-designated Cancer Centers provide evidence-based smoking cessation to patients diagnosed with and treated for cancer. The C3I is coordinated at the University of Wisconsin-Center for Tobacco Research and Intervention (UW-CTRI) and the University of Wisconsin Carbone Cancer Center (UWCCC). Twenty-one health systems across the U.S. will provide EHR data to the UW-CTRI coordinating center on all COVID-19 patients identified during the period from February 1, 2020, through January 31, 2022.
Current EHR-based data elements collected will include:
Evidence of COVID-19: ICD-10-CM diagnosis of COVID-19, COVID-19 PCR lab test, and/or COVID-19 antigen lab test
Healthcare system encounter type: inpatient, outpatient, emergency department (ED), urgent care, or other
SES/Demographics variables: insurance status, education, housing status, sex, age, race/ethnicity, height, weight, body mass index
Comorbid diseases: chronic asthma, chronic COPD, chronic bronchiectasis, diabetes mellitus, cardiovascular disease, chronic renal disease, on dialysis, immunocompromised [due to SLE lupus, rheumatoid arthritis, organ transplant, HIV, Crohn's], pregnant, cancer (lymphomas, leukemias, lung/respiratory, rectal, breast, prostate, pancreas), hypertension, depression, anxiety, alcohol abuse, pro- clotting disorders, and anti-clotting disorders
Tobacco use variables: smoking status (current, former, never), passive smoke exposure for never smoker, years since quitting (for former smokers), packs smoked per day, years of smoking, pack years, smokeless tobacco user, and marijuana use
Signs and symptoms: temperature, pulse, systolic blood pressure, diastolic blood pressure, oxygen saturation, septic shock, pneumonia, chills, muscle aches/myalgia, rhinorrhea, sore throat, chronic cough, shortness of breath, nausea or vomiting, headache, abdominal pain, diarrhea, dizziness, impaired consciousness, acute cerebrovascular event, ataxia, seizure, taste impairment, smell impairment, vision impairment, nerve pain, and skeletal muscular pain
COVID-19 treatment variables: ICU admission, required supplemental oxygen, intubated for ventilator use, noninvasive positive pressure, and number of days hospitalized
COVID-19 medications including (but not limited to): chloroquine, hydroxychloroquine, tocilizumab, remdesivir, dexamethasone, convalescent plasma, and ascorbic acid
Classes of other medications used: nicotine replacement therapies (NRTs), varenicline medications; blood thinners, steroids, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), short-acting adrenergic bronchodilators, long-acting adrenergic bronchodilators, anticholinergic bronchodilators, bronchodilators combos, inhaled corticosteroids (includes combo medications), and inhaled corticosteroid bronchodilators
Lab tests: COVID-19 PCR test, COVID-19 Antigen test, Albumin, ALT, Bicarbonte, BUN, Calcium, C-Reactive Protein, High Sensitivity, C-Reactive Protein, Creatinine, D-DIMER, ESR, Ferritin, Hematocrit, HgbA1c., INR, LDH, Leukocytes, Platelet Count, Potassium, Procalcitonin, Sodium, Troponin-I, Troponin-T
For the initial paper(s) to be prepared based on these data, the main analytic methods will include GUIDE classification and regression tree models. However, whole sample methods will also be used as complementary analytic methods, which will vary with regard to outcome type: i.e., logistic regression for binary outcomes and Cox proportional hazard analyses for time-to-event outcomes. Initial analyses will focus on hospitalized COVID-19 patients. Later waves of analyses may use different analytic approaches and address different questions.
Participating healthcare systems:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,634,381 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with COVID-19 in the 21 participating healthcare systems
Exclusion Criteria:
Analyses of the cohort data will include (1) all patients, or (2) hospitalized patients meeting specific inclusion criteria.
Mortality due to COVID-19
In analyses of hospitalized patients, all-cause mortality in patients with COVID-19 illness vs discharge from hospital (binary outcome)
Time frame: February 1, 2020, through January 31, 2022
COVID-19 Severity
In analyses of hospitalized patients, COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization; binary outcome)
Time frame: February 1, 2020, through January 31, 2022
Plan to share: Yes — The Limited data set will be secured, cleaned, harmonized, and undergo initial analyses in mid to late 2022.The existing Data Transfer and Use Agreements (DTUA) negotiated with each 21 participating health systems precludes the University of Wisconsin (UW) from sharing these data with any entity at this time. This was a requirement of the UW IRB prior to transferring the de-identified site data sets to UW. Starting in 2023, investigators desiring access to CEC-UW data will need to apply for access via an NCI contractor organization, Information Management Services (IMS; https://www.imsweb.com/).
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison