Biospecimen Collection: Undergo collection of blood samples
Data Collection: Undergo collection of medical information and imaging
Quality-of-Life Assessment: Complete quality of life questionnaires
Questionnaire Administration: Complete quality of life questionnaires
Study summary
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* NCCAPS STUDY ELIGIBILITY CRITERIA:
* Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) and cancer treatment that fits into one of the three following categories:
* Metastatic (stage IV) solid tumor, any hematologic malignancy, or any central nervous system (CNS) malignancy, and:
* Patient is receiving eligible active treatment (defined as current treatment or treatment within the 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment
* Eligible active treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy; OR
* Non-metastatic (Stage I-III) solid tumor and:
* Patient is receiving eligible active treatment (defined as current treatment or treatment within past 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment
* Eligible active treatment types for non-metastatic solid tumor patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy (except as noted below)
* HER2-targeted therapy (trastuzumab, pertuzumab, neratinib, ado-trastuzumab) that is not accompanied by chemotherapy is NOT considered an eligible active treatment
* Patients on endocrine therapy alone are not eligible; OR
* Prior or current transplant for the treatment of cancer:
* Patient has received an allogenic stem cell/bone marrow transplant or chimeric antigen receptor (CAR)-T cell or other modified cellular therapy at any time; or
* Patient is currently receiving treatment or prophylaxis for graft versus (vs.) host disease; or
* Patient has received an autologous stem cell/bone marrow transplant within the past 2 years
* Patient must have documented positive viral test result for SARS-CoV-2
* For patients 18 years of age or older, the specimen collection for the patient's FIRST positive test must have occurred no earlier than 14 days prior to enrollment
* For patients under 18 years of age, the specimen collection for the patient's first positive test must have occurred after January 31, 2020
* The viral test can be either a nucleic acid (polymerase chain reaction \[PCR\]) test or an antigen test. Serological or antibody tests are not allowed
* Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test
* Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again
* The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance with the most recent guidance issued by the Food and Drug administration (FDA) in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. This policy is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised
* Human immunodeficiency virus (HIV)-infected patients are eligible
* Patients with CNS metastases are eligible
* Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed
* PEDIATRIC COVNET COHORT ELIGIBILITY CRITERIA:
Patients should only be enrolled in the pediatric COVNET cohort if they are not eligible for the main NCCAPS Study cohort or decline to participate in the main study
* Patient must be \< 18 years of age
* Patient must have a positive SARS-CoV-2 viral test after January 31, 2020
* Patient must have a current or prior diagnosis of cancer. Active cancer treatment is not required
* Note: Patients who enroll on Pediatric COVNET cohort will not be followed longitudinally; study data collection involves only a single questionnaire and research blood collection. A separate consent document is provided for the Pediatric COVNET cohort
Primary outcome measure(s)
Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity — Up to 2 years Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit \[ICU\] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.
Effects of COVID-19 on cancer therapy and association with clinical outcomes — Up to 2 years Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for pediatric patients and subgroups of adult patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.
Physical health (patient-reported health-related quality of life) — Up to 2 years Will be measured using items from the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile.
Trial sites (932)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Veterans Administration Medical Center - Birmingham
Birmingham
Alabama
USA Health Strada Patient Care Center
Mobile
Alabama
Anchorage Associates in Radiation Medicine
Anchorage
Alaska
Anchorage Radiation Therapy Center
Anchorage
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska
Alaska Oncology and Hematology LLC
Anchorage
Alaska
Alaska Women's Cancer Care
Anchorage
Alaska
Anchorage Oncology Centre
Anchorage
Alaska
Katmai Oncology Group
Anchorage
Alaska
Providence Alaska Medical Center
Anchorage
Alaska
Fairbanks Memorial Hospital
Fairbanks
Alaska
Kingman Regional Medical Center
Kingman
Arizona
Banner Children's at Desert
Mesa
Arizona
Cancer Center at Saint Joseph's
Phoenix
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Arizona
Mayo Clinic in Arizona
Scottsdale
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
NEA Baptist Memorial Hospital
Jonesboro
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arkansas
Kaiser Permanente-Anaheim
Anaheim
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
California
PCR Oncology
Arroyo Grande
California
Kaiser Permanente-Baldwin Park
Baldwin Park
California
Kaiser Permanente-Bellflower
Bellflower
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
California
Enloe Medical Center
Chico
California
Adventist Health Cancer Care Center Chico
Chico
California
UC Irvine Health Cancer Center-Newport
Costa Mesa
California
Kaiser Permanente Dublin
Dublin
California
Kaiser Permanente-Fontana
Fontana
California
Kaiser Permanente-Fremont
Fremont
California
Fresno Cancer Center
Fresno
California
Kaiser Permanente-Fresno
Fresno
California
Kaiser Permanente South Bay
Harbor City
California
Kaiser Permanente-Irvine
Irvine
California
UC San Diego Moores Cancer Center
La Jolla
California
+ 892 more sites — see the full list on the official registry below.
More National Cancer Institute (NCI) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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