Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Costa Mesa, California and other locations
Dates
study started
estimated completion
Principal Investigator
Susan M. O'Brien

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19), including severity and fatality, in cancer patients undergoing treatment.

II. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation.

III. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

CORRELATIVE OBJECTIVES:

  1. Future correlative biomarker objectives will include assessment of the development of SARS coronavirus 2 (SARS CoV-2) antibodies, description of the trajectory of cytokine abnormalities, and genome-wide association studies to define polymorphisms associated with severe COVID-19.

II. Future correlative imaging objectives will include assessment of COVID-19 sequelae in cancer patients.

III. Collection and banking of research blood specimens and radiological images for future research.

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 up to 9 times at the same times they receive routine bloodwork. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times.

Keywords

Asymptomatic COVID-19 Infection Laboratory-Confirmed Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed COVID-19 Infection Communicable Diseases Laboratory Infection Neoplasms Biospecimen Collection Data Collection

Eligibility

For people ages 18 years and up

Inclusion Criteria:

  • STEP 0 ELIGIBILITY CRITERIA:
  • Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) that fits into any one of the following categories:
  • Patient is receiving active treatment (defined as current treatment or treatment within the past 6 weeks) for metastatic cancer. Eligible 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, or radiation therapy; or
  • Patients is receiving adjuvant treatment for non-metastatic (stage I-III) cancer and has received intravenous chemotherapy, immunotherapy, targeted therapy, or radiation therapy within the past 6 weeks; or
  • Patient has received an allogenic stem cell 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 versus (vs.) host disease; or
  • Patient has received an autologous bone marrow transplant within the past 2 years.
  • Patient must be undergoing or have undergone testing for SARS CoV-2. Patients with prior negative SARS CoV-2 test(s) are eligible if they are being tested again. Patients with prior positive SARS CoV-2 test(s) more than 14 days prior to enrollment are not eligible
  • Human immunodeficiency virus (HIV)-infected patients are eligible
  • Patients with brain metastases are eligible
  • Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed
  • STEP 1 ELIGIBILITY CRITERIA: Positive SARS CoV-2 test within the 14 days prior to enrollment to Step 1.
  • Patient must have a documented positive SARS CoV-2 test. The positive test results must have been received no earlier than 14 days prior to enrollment to Step 1. The test must have been ordered by a doctor's office, hospital, or department of public health. Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the SARS CoV-2 test.

Locations

  • UC Irvine Health Cancer Center-Newport accepting new patients
    Costa Mesa California 92627 United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • Kaiser Permanente-Irvine accepting new patients
    Irvine California 92618 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04387656
Study Type
Observational
Last Updated