NCT04387656

NCI COVID-19 in Cancer Patients, NCCAPS Study

NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,877 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• COVID-19 Infection
• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Data Collection	Undergo collection of medical information and imaging
OTHER	Quality-of-Life Assessment	Complete quality of life questionnaires
OTHER	Questionnaire Administration	Complete quality of life questionnaires

Timeline

• Start date: 2020-06-05
• Primary completion: 2024-03-20
• Completion: 2026-10-03
• First posted: 2020-05-14
• Last updated: 2026-04-13

Locations

935 sites across 3 countries: United States, Canada, Puerto Rico