NCI COVID-19 in Cancer Patients, NCCAPS Study

Summary

Objectives

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.