NCI COVID-19 in Cancer Patients, NCCAPS Study

Malignant Solid Neoplasm Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection
• Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Neoplasms

• NCT number: NCT04387656
• Study type: Observational
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Start date: June 5, 2020
• Completion date: March 20, 2025