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Clinical Trials in Canada / NCT04387656
Active, not recruiting Observational

NCI COVID-19 in Cancer Patients, NCCAPS Study

NCT04387656 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2020-06-05
Last updated
2026-10-01

Condition(s) studied

COVID-19 InfectionHematopoietic and Lymphatic System NeoplasmMalignant Solid NeoplasmMetastatic Malignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Biospecimen CollectionData CollectionQuality-of-Life AssessmentQuestionnaire Administration

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)

Trial sites (932)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT04387656 on ClinicalTrials.gov ↗ ← All trials in Canada