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ASCO Survey on COVID-19 in Oncology (ASCO) Registry

Sponsor
American Society of Clinical Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT04659135
Collaborator
(none)
7,000
Enrollment
85
Locations
67.4
Anticipated Duration (Months)
82.4
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The American Society of Clinical Oncology (ASCO) Survey on Coronavirus 2019 (COVID-19) in Oncology Registry (ASCO Registry) aims to help the cancer community learn more about the patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how COVID-19 is impacting the delivery of cancer care and patient outcomes. The ASCO Registry collects both baseline and follow-up data on how the virus impacts cancer care and cancer patient outcomes during the COVID-19 pandemic.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Rationale:

    The COVID-19 Pandemic presents a unique opportunity to capture information on how a disease outbreak affects delivery of high-quality cancer care. ASCO is providing the means for the oncology community to rapidly submit data that will inform both current cancer care and provide information to help guide decision-making for future disease outbreaks. While other entities have launched COVID-19 cancer registries, ASCO's registry collects information about patients undergoing treatment for cancer and with confirmed COVID-19 infection based on a positive test. Unlike other registries, ASCO's registry collects follow-up information on both COVID-19 disease and cancer outcomes at 30-day intervals for the first 90 days and 90-day intervals thereafter up to one year after COVID-19 diagnosis.

    Project Objectives:

    Capture and describe cancer and COVID-19 status at COVID-19 diagnosis, and cancer and COVID-19 outcomes of patients with cancer and COVID-19 from participating cancer practices/institutions. Data collected includes treatment approaches, cancer status, changes to cancer treatment plans in patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, status of COVID-19 infection (e.g., severity of symptoms, need for ventilator, hospitalization, etc.) and cancer (e.g., cancer progression, treatment-related changes/modifications, etc.).

    Research Objectives:

    Objective 1: Describe the distribution of symptoms and severity of COVID-19 among patients with cancer (on active treatment or on adjuvant treatment within 12 months after surgical resection) who have confirmed infection of SARS-CoV-2 •Objective 1.1: Describe distribution of symptoms and severity of COVID-19 stratified according to demographic characteristics, including age, cancer type, cancer extent, race, ethnicity, geography, type of therapy received, smoking status, comorbidities, etc.

    •Objective 1.2: Identify characteristics independently associated with severity of COVID-19 in cancer patients.

    Objective 2: Examine SARS-CoV-2 viral infection outcomes (ongoing, recovery, hospitalized, not in ICU; hospitalized in ICU; placed on ventilator; death due to COVID-19 disease complications) and cancer outcomes (stable, response to treatment, progression, delayed treatment, treatment discontinued, and death)

    • Objective 2.1: Stratify patients with SARS-CoV-2 viral infection according to characteristics described in Objective 1.1 to examine whether any of the characteristics are independently associated with COVID-19 and/or cancer outcomes

    • Objective 2.2: Examine the relationship between SARS-CoV-2 viral infection outcomes and cancer outcomes and whether SARS-CoV-2 viral infection outcomes are independently associated with cancer outcomes

    Objective 3: To describe effects of the COVID-19 pandemic on cancer practices in the U.S., including changes in staffing and resource availability, priorities for patient care, and modification of interactions between care providers and patients (including use of telemedicine)

    Eligibility Criteria:

    The registry collects data about patients with a cancer diagnosis who have a confirmed SARS-CoV-2 infection and are being treated at participating cancer practices/institutions within the United States. Patients in one of the four categories are eligible:

    1. Patients with a new cancer diagnosis and in the process of cancer staging and/or receipt of initial cancer therapy

    2. Patients with clinically evident cancer receiving anti-cancer treatment,

    3. Patients who are disease free, but receiving any type of adjuvant therapy within 1 year following surgical resection (including hormonal treatments), and

    4. Patients with clinically evident cancer receiving supportive care only.

    Statistical Considerations and Reporting:

    ASCO's Center for Research and Analytics (CENTRA) reports via a data dashboard (https://www.asco.org/covid-resources/asco-registry/data-dashboard) to the general cancer community key characteristics of patients in the Registry. ASCO also submits abstracts for presentation and manuscripts for publication. Reports summarize overall data and stratified by patient characteristics, such as disease sites and stage, age and comorbidities. Reports or publications will also include cancer treatment delay and discontinuation of cancer treatments including surgery, radiation and drug-based therapies, due to the patient's COVID-19 disease and to other factors, with stratification by other variables as described above. Changes in practice patterns of care, staffing, resources, and interactions with patients will also be evaluated and summarized.

    As there is no hypothesis testing planned, there is no required sample size and providing reports also provided to other registries, with cumulative information, will not affect validity of results. Confidence intervals will be provided where appropriate to demonstrate precision of estimates.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    7000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    ASCO Survey on Coronavirus Disease 2019 (COVID-19) in Oncology (ASCO) Registry
    Actual Study Start Date :
    Apr 19, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Changes to Cancer Treatments [24 months]

      Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics

    Secondary Outcome Measures

    1. All-cause mortality at 30 days [30 days]

      Any patient deaths that occurred as measured by number of days after COVID-19 diagnosis

    2. COVID-19 Symptoms [24 months]

      Yes vs. no response to reported COVID-19 symptoms

    3. COVID-19 Treatments [24 months]

      Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics

    4. Patient vital status [24 months]

      Alive vs. dead up to 24 months from COVID-19 diagnosis

    5. Overall survival [24 months]

      Time to event endpoint measured as the time from covid-19 dx to death, censored at the last time patient was known to be alive if there is no death date provided.

    6. Patient cancer status (for patients who had active cancer at covid-19 dx) [24 months]

      Categorical variable of cancer status, compared to time at COVID-19 diagnosis (stable, responding to therapy, progressed). This will be measured over time (longitudinally) and can take different values for the same patient at different time points.

    7. Patient cancer status (for patients who are disease-free at COVID-19 diagnosis) [24 months]

      An indicator (yes v no) of whether the patients cancer has relapsed since COVID-19 diagnosis. This will be measured over time (longitudinally) and can take different values for the same patient at different time points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • COVID-19 positive diagnosis

    • One of the following;

    1. Patient has active cancer at the time of COVID-19 diagnosis OR

    2. Patient has been cancer-free for less than 12 months AND receiving adjuvant therapy at the time of COVID-19 diagnosis

    Exclusion Criteria:

    • COVID-19 suspected, but no positive test result

    • Patient is a cancer-free not receiving any anti-cancer or adjuvant treatment

    • Patient is receiving adjuvant therapy, but has been cancer-free for up to 12 months at the time of COVID-19 diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 Infirmary Cancer Care Mobile Alabama United States 36607
    3 Anchorage Oncology Center Anchorage Alaska United States 99508
    4 AIS Cancer Center Bakersfield California United States 93301
    5 Long Beach Memorial Medical Center Fountain Valley California United States 92708
    6 Orange Coast Medical Center Fountain Valley California United States 92708
    7 Saddleback Memorial Medical Center Fountain Valley California United States 92708
    8 Helen Diller Family Comprehensive Cancer Center, UCSF San Francisco California United States 94118
    9 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    10 PIH Health Whittier California United States 90602
    11 Sarah Cannon Research Institute at HealthONE Denver Colorado United States 80218
    12 Hartford HealthCare Cancer Institute Hartford Connecticut United States 06102
    13 Day Kimball Healthcare Putnam Connecticut United States 06260
    14 Bayhealth Medical Center Dover Delaware United States 19901
    15 Florida Precision Oncology, A Division of 21st Centry Oncology Fort Myers Florida United States 33907
    16 Florida Cancer Specialists - Sarah Cannon Research Institute Sarasota Florida United States 34236
    17 University of South Florida Tampa Florida United States 33612
    18 Emory University Winship Cancer Institute Atlanta Georgia United States 30322
    19 Augusta University Augusta Georgia United States 30912
    20 Cancer Center of Middle Georgia, LLC Dublin Georgia United States 31021
    21 Hawaii Cancer Care Honolulu Hawaii United States 96813
    22 University of Chicago Chicago Illinois United States 60637
    23 NorthShore University HealthSystem Evanston Illinois United States 60201
    24 OSF Little Company of Mary Hospital Evergreen Park Illinois United States 60805
    25 Joliet Oncology-Hematology Associates Joliet Illinois United States 60435
    26 Edward-Elmhurst Healthcare Naperville Illinois United States 60540
    27 Illinois Cancer Care Peoria Illinois United States 61615
    28 Quincy Medical Group Cancer Institute Quincy Illinois United States 62301
    29 Goshen Center for Cancer Care Goshen Indiana United States 46526
    30 Michiana Hematology Oncology Mishawaka Indiana United States 46545
    31 Midwest Oncology Associates - Sarah Cannon Research Institute Overland Park Kansas United States 66215
    32 University of Kansas Medical Center Westwood Kansas United States 66205
    33 Baptist Health Madisonville Madisonville Kentucky United States 42431
    34 Pontchartrain Cancer Center Hammond Louisiana United States 70403
    35 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    36 LifeBridge Health Baltimore Maryland United States 21215
    37 Saint Agnes Hospital Cancer Institute Baltimore Maryland United States 21229
    38 Tufts Medical Center Boston Massachusetts United States 02111
    39 Rogel Cancer Center University of Michigan Ann Arbor Michigan United States 48109
    40 Great Lakes Cancer Management Specialists Grosse Pointe Woods Michigan United States 48236
    41 Lakeland Hospitals Saint Joseph Michigan United States 49085
    42 Mayo Clinic Rochester Minnesota United States 55905
    43 Boone Hospital Center Columbia Missouri United States 65201
    44 Mosaic Cancer Care Saint Joseph Missouri United States 64507
    45 Nebraska Hematology Oncology Lincoln Nebraska United States 68506
    46 Callahan Cancer Center North Platte Nebraska United States 69101
    47 Nebraska Cancer Specialists Omaha Nebraska United States 68130
    48 University of Nebraska Medical Center Omaha Nebraska United States 68198
    49 Bayonne Medical Center Bayonne New Jersey United States 07002
    50 CarePoint Health - Christ Hospital Jersey City New Jersey United States 07306
    51 Penn Medicine, Princeton Health Plainsboro New Jersey United States 08536
    52 Hematology Oncology Associates of Central New York East Syracuse New York United States 13057
    53 Northwell Health Cancer Institute Lake Success New York United States 11042
    54 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    55 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    56 Levine Cancer Institute Atrium Health Charlotte North Carolina United States 28204
    57 East Carolina University Greenville North Carolina United States 27858
    58 Carteret Health Care Morehead City North Carolina United States 28557
    59 CarolinaEast Medical Center New Bern North Carolina United States 28560
    60 Regional Medical Oncology Center Wilson North Carolina United States 27893
    61 Aultman Hospital Canton Ohio United States 44710
    62 Cincinnati Children's Hospital Cincinnati Ohio United States 45229
    63 Oncology Hematology Care Cincinnati Ohio United States 45242
    64 University Hospitals Seidman Cancer Center Cleveland Ohio United States 44106
    65 TriCounty Hematology and Oncology Massillon Ohio United States 44646
    66 Columbia Memorial Hospital Astoria Oregon United States 97103
    67 Samaritan Health Services Corvallis Corvallis Oregon United States 97330
    68 Penn Medicine, Lancaster General Health Lancaster Pennsylvania United States 17604
    69 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    70 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    71 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    72 Lexington Oncology West Columbia South Carolina United States 29169
    73 Monument Health Rapid City South Dakota United States 57701
    74 Kirkland Cancer Center Jackson Tennessee United States 38301
    75 Baptist Clinical Research Institute Memphis Tennessee United States 38120
    76 Tennessee Oncology Nashville Tennessee United States 37203
    77 BSA Harrington Cancer Center Amarillo Texas United States 79106
    78 The START Center for Cancer Care San Antonio Texas United States 78229
    79 University of Texas, Health Science Center San Antonio Texas United States 78229
    80 Virginia Cancer Specialists Fairfax Virginia United States 22031
    81 Augusta Health Fishersville Virginia United States 22939
    82 Hematology Oncology Associates of Fredericksburg Fredericksburg Virginia United States 22408
    83 Virginia Cancer Institute Richmond Virginia United States 23230
    84 PeaceHealth Vancouver Washington United States 98664
    85 The Cancer Team at Bellin Health Green Bay Wisconsin United States 54313

    Sponsors and Collaborators

    • American Society of Clinical Oncology

    Investigators

    • Principal Investigator: Julie R Gralow, MD, American Society of Clinical Oncology
    • Study Director: Suanna S Bruinooge, MPH, American Society of Clinical Oncology
    • Study Director: Elizabeth Garrett-Mayer, PhD, American Society of Clinical Oncology

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    American Society of Clinical Oncology
    ClinicalTrials.gov Identifier:
    NCT04659135
    Other Study ID Numbers:
    • Pro00014181
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by American Society of Clinical Oncology
    Cancer
    Additional relevant MeSH terms:
    Coronavirus Infections

    Study Results

    No Results Posted as of Mar 10, 2022