Заболявания:
COVID-19 Infection
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Спонсор: National Cancer Institute (NCI)
Налично на:
БГ
Обобщение
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.
Описание
PRIMARY OBJECTIVES:
I. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of coronavirus 2019 (COVID-19), including symptoms, severity, and fatality, in adult and pediatric cancer patients undergoing treatment.
II. Describe cancer treatment modifications made in response to COVID-19 in adult and pediatric patients, including dose adjustments, changes in symptom management, or temporary or permanent cessation.
III. Evaluate the association of COVID-19 with cancer outcomes in adult patient subgroups defined by clinico-pathologic characteristics and in pediatric patients.
EXPLORATORY CORRELATIVE OBJECTIVES:
I. Study the immune response to COVID-19 in patients with cancer by assessing cytokines by Olink profiling and the cellular compartment of the immune system using mass cytometry (CyTOF).
II. Describe coagulation abnormalities in COVID-19 cancer patients. III. Describe the development of severe acute respiratory syndrome (SARS) coronavirus 2 (SARS CoV-2) antibodies and neutralizing antibodies in cancer patients.
IV. Investigate both common and rare genetic variants associated with differences in disease outcome using a case-case design to increase understanding of COVID-19 disease in cancer patients using large-scale genome-wide association studies and whole genome sequencing.
V. Characterize the development and longevity of vaccine-induced immunity using serology (ligand-binding assays) and neutralizing antibodies.
VI. Collect and bank research blood specimens and radiological images for future research.
PATIENT-REPORTED HEALTH-RELATED QUALITY OF LIFE OBJECTIVES:
I. Describe patient-reported short-and long-term physical health, defined as a composite of physical function, pain interference and intensity, and ability to participate in social roles and activities, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-29 version (v)2.0 profile in adult cancer patients diagnosed with COVID-19. (Primary) II. Describe patient-reported short-and long-term symptoms (anxiety, depression, and dyspnea) and function (cognitive function and social isolation) in adult cancer patients diagnosed with COVID-19. (Secondary) III. Assess how patient-reported physical health (primary objective) and symptoms and function (secondary objective) in adult cancer patients vary by COVID-19 symptom burden, cancer type, cancer treatment, comorbidities, tobacco use, body mass index, and demographic characteristics. (Exploratory)
PEDIATRIC COVNET COHORT OBJECTIVE (FOR PATIENTS \< 18 YEARS OLD):
I. Investigate both common and rare variants associated with differences in disease outcome using a case-case design for children and adolescents, \< 18 years old to increase understanding of COVID-19 in pediatric cancer patients.
OUTLINE:
Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer
Кой може да участва
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
Интервенции
Biospecimen Collection
PROCEDURE
Data Collection
OTHER
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Места на провеждане
935
Канада (2)
CSSS Champlain-Charles Le Moyne
Greenfield Park , Quebec
Kingston Health Sciences Centre
Kingston , Ontario
Puerto Rico (2)
University Pediatric Hospital
San Juan
Centro Comprensivo de Cancer de UPR
San Juan
САЩ (931)
Providence Regional Cancer System-Aberdeen
Aberdeen , Washington
Summa Health System - Akron Campus
Akron , Ohio
Cleveland Clinic Akron General
Akron , Ohio
Children's Hospital Medical Center of Akron
Akron , Ohio
Phoebe Putney Memorial Hospital
Albany , Georgia
University of New Mexico Cancer Center
Albuquerque , New Mexico
Lehigh Valley Hospital-Cedar Crest
Allentown , Pennsylvania
OSF Saint Anthony's Health Center
Alton , Illinois
Community Hospital of Anaconda
Anaconda , Montana
Kaiser Permanente-Anaheim
Anaheim , California
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
AnMed Health Cancer Center
Anderson , South Carolina
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor , Michigan
C S Mott Children's Hospital
Ann Arbor , Michigan
University of Michigan Rogel Cancer Center
Ann Arbor , Michigan
Langlade Hospital and Cancer Center
Antigo , Wisconsin
Kaiser Permanente-Deer Valley Medical Center
Antioch , California
ThedaCare Regional Cancer Center
Appleton , Wisconsin
Ascension Saint Elizabeth Hospital
Appleton , Wisconsin
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande , California
PCR Oncology
Arroyo Grande , California
University Cancer and Blood Center LLC
Athens , Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta , Georgia
Hematology Oncology Associates of Central New York-Auburn
Auburn , New York
Harold Alfond Center for Cancer Care
Augusta , Maine
Augusta Oncology Associates PC-D'Antignac
Augusta , Georgia
Augusta Oncology Associates PC-Wheeler
Augusta , Georgia
Augusta University Medical Center
Augusta , Georgia
Rocky Mountain Cancer Centers-Aurora
Aurora , Colorado
The Medical Center of Aurora
Aurora , Colorado
Rocky Mountain Regional VA Medical Center
Aurora , Colorado
Rush-Copley Medical Center
Aurora , Illinois
Dell Children's Medical Center of Central Texas
Austin , Texas
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura , Florida
Saint Alphonsus Cancer Care Center-Baker City
Baker City , Oregon
Kaiser Permanente-Baldwin Park
Baldwin Park , California
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin , Missouri
University of Maryland/Greenebaum Cancer Center
Baltimore , Maryland
Mercy Medical Center
Baltimore , Maryland
Greater Baltimore Medical Center
Baltimore , Maryland
Sinai Hospital of Baltimore
Baltimore , Maryland
Kaiser Permanente-Woodlawn Medical Center
Baltimore , Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore , Maryland
Eastern Maine Medical Center
Bangor , Maine
Flaget Memorial Hospital
Bardstown , Kentucky
Memorial Sloan Kettering Basking Ridge
Basking Ridge , New Jersey
Medical Center of Baton Rouge
Baton Rouge , Louisiana
Louisiana Hematology Oncology Associates
Baton Rouge , Louisiana
Our Lady of the Lake Medical Oncology
Baton Rouge , Louisiana
Woman's Hospital
Baton Rouge , Louisiana
Ochsner High Grove
Baton Rouge , Louisiana
LSU Health Baton Rouge-North Clinic
Baton Rouge , Louisiana
Our Lady of the Lake Physician Group
Baton Rouge , Louisiana
Louisiana Hematology Oncology Associates LLC
Baton Rouge , Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge , Louisiana
Bronson Battle Creek
Battle Creek , Michigan
McLaren Cancer Institute-Bay City
Bay City , Michigan
Baptist Hospitals of Southeast Texas Cancer Center
Beaumont , Texas
Indu and Raj Soin Medical Center
Beavercreek , Ohio
MaineHealth Waldo Hospital
Belfast , Maine
Overlake Medical Center
Bellevue , Washington
Nebraska Medicine-Bellevue
Bellevue , Nebraska
Kaiser Permanente-Bellflower
Bellflower , California
PeaceHealth Saint Joseph Medical Center
Bellingham , Washington
Strecker Cancer Center-Belpre
Belpre , Ohio
Sanford Joe Lueken Cancer Center
Bemidji , Minnesota
Saint Charles Health System
Bend , Oregon
ThedaCare Cancer Care - Berlin
Berlin , Wisconsin
Lehigh Valley Hospital - Muhlenberg
Bethlehem , Pennsylvania
Beverly Hospital
Beverly , Massachusetts
MaineHealth Maine Medical Center - Biddeford
Biddeford , Maine
Southern Maine Health Center/Biddeford Medical Center
Biddeford , Maine
Billings Clinic Cancer Center
Billings , Montana
Saint Vincent Healthcare
Billings , Montana
Saint Vincent Frontier Cancer Center
Billings , Montana
University of Alabama at Birmingham Cancer Center
Birmingham , Alabama
Veterans Administration Medical Center - Birmingham
Birmingham , Alabama
Sanford Bismarck Medical Center
Bismarck , North Dakota
Illinois CancerCare-Bloomington
Bloomington , Illinois
Saint Joseph's/Candler - Bluffton Campus
Bluffton , South Carolina
Saint Elizabeth Boardman Hospital
Boardman , Ohio
Prisma Health Cancer Institute - Spartanburg
Boiling Springs , South Carolina
Saint Alphonsus Cancer Care Center-Boise
Boise , Idaho
Saint Luke's Cancer Institute - Boise
Boise , Idaho
Central Care Cancer Center - Bolivar
Bolivar , Missouri
Tufts Medical Center
Boston , Massachusetts
Boulder Community Foothills Hospital
Boulder , Colorado
Rocky Mountain Cancer Centers-Boulder
Boulder , Colorado
Bozeman Health Deaconess Hospital
Bozeman , Montana
Florida Cancer Specialists - Bradenton Cancer Center
Bradenton , Florida
Cox Cancer Center Branson
Branson , Missouri
Northeast Georgia Medical Center Braselton
Braselton , Georgia
Lafayette Family Cancer Center-EMMC
Brewer , Maine
Ocean University Medical Center
Brick , New Jersey
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton , Michigan
Trinity Health Medical Center - Brighton
Brighton , Michigan
University of Michigan - Brighton Center for Specialty Care
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