NCI COVID-19 in Cancer Patients, NCCAPS Study

Official Title

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

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.

Trial Description

Primary Outcome:

  • Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity
  • Effects of COVID-19 on cancer therapy and association with clinical outcomes
  • Physical health (patient-reported health-related quality of life)
PRIMARY OBJECTIVES:
  • Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of coronavirus 2 (COVID-19), including symptoms, severity, and fatality, in adult and pediatric cancer patients undergoing treatment.
  • 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.
  • Evaluate the association of COVID-19 with cancer outcomes in adult patient subgroups defined by clinico-pathologic characteristics and in pediatric patients.
CORRELATIVE OBJECTIVES:
  • Future correlative biomarker objectives will include assessment of the development of severe acute respiratory syndrome (SARS) coronavirus 2 (SARS CoV-2) antibodies, description of the trajectory of cytokine abnormalities, description of coagulopathies, and genome-wide association studies to define polymorphisms associated with severe COVID-19.
  • Collection and banking of research blood specimens and radiological images for future research.
PATIENT-REPORTED HEALTH-RELATED QUALITY OF LIFE OBJECTIVES:
  • 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)
  • 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)
  • 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)
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 9 times for adults and up to 6 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society