nci covid-19 in cancer patients, nccaps study

Conditions: COVID-19 Infection; Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm

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.

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 treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. patients who are hospitalized for covid-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. adult patients also complete quality of life questionnaire.

Eligibility criteria:
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 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

Keywords: covid-19