Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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) or will begin receiving treatment within the next 2
weeks for any central nervous system (CNS) or hematologic malignancy or
metastatic (stage IV) solid tumor. Eligible treatment types for hematologic
malignancy or metastatic cancer are chemotherapy, immunotherapy, monoclonal
antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy
(e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation
therapy, or targeted radionuclide therapy; or

- Patient is receiving treatment (defined as current treatment or treatment within
the past 6 weeks) or will begin receiving treatment within the next 2 weeks for
non-metastatic (stage I-III) solid tumor. Eligible treatment types for
non-metastatic cancer patients are intravenous chemotherapy, immunotherapy,
targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal
antibody therapy, except trastuzumab/pertuzumab if not accompanied by
chemotherapy; 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 have a pending or known positive viral test result for SARS-CoV-2.
Patients with prior negative viral SARS CoV-2 test(s) are eligible if they are being
tested again. Patients 18 years of age and older with prior positive viral SARS CoV-2
test(s) more than 14 days prior to enrollment to Step 1 are not eligible

- Human immunodeficiency virus (HIV)-infected patients are eligible

- Patients with CNS metastases are eligible

- Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed

- STEP 1 ELIGIBILITY CRITERIA: Positive viral SARS CoV-2 test

- Patient must have a documented positive viral SARS CoV-2 test

- For patients 18 years of age or older, the specimen collection for the
positive test must have occurred no earlier than 14 days prior to enrollment
to Step 1

- For patients under 18 years of age, the specimen collection for the positive
test must have occurred after January 31, 2020

- The viral test can be either a nucleic acid (PCR) test or an antigen test.
Serological or antibody tests are not allowed. The test must have received
Emergency Use Approval (EUA) from the Food and Drug Administration (FDA) and be
performed in a Clinical Laboratory Improvement Act (CLIA) certified lab or
patient care setting operating under a CLIA Certificate of Waiver. A full list of
tests that have been approved under the EUA can be accessed at:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-u
se-authorizations-medical-devices/vitro-diagnostics-euas Any specimen source
(e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral
SARS-CoV-2 test.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational Cohort (data collection, biospecimen collection) 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.
  • 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 names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete quality of life questionnaires

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

More Details

Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Study Contact

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 2 (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. CORRELATIVE OBJECTIVES: I. 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. II. Collection and banking of 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) 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.