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:

- NCCAPS STUDY ELIGIBILITY CRITERIA:

- Patient must have a prior or current cancer diagnosis (e.g., solid tumor or
hematologic malignancy) and cancer treatment that fits into one of the three following
categories:

- Metastatic (stage IV) solid tumor, any hematologic malignancy, or any central
nervous system (CNS) malignancy, and:

- Patient is receiving eligible active treatment (defined as current treatment
or treatment within the 6 weeks prior to their first positive SARS-CoV-2
test collection) or is expected to begin receiving treatment within 2 weeks
of study enrollment

- Eligible active 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, radiation
therapy, or targeted radionuclide therapy; OR

- Non-metastatic (Stage I-III) solid tumor and:

- Patient is receiving eligible active treatment (defined as current treatment
or treatment within past 6 weeks prior to their first positive SARS-CoV-2
test collection) or is expected to begin receiving treatment within 2 weeks
of study enrollment

- Eligible active treatment types for non-metastatic solid tumor patients are
intravenous chemotherapy, immunotherapy, targeted therapy, radiation
therapy, targeted radionuclide therapy, or monoclonal antibody therapy
(except as noted below)

- HER2-targeted therapy (trastuzumab, pertuzumab, neratinib,
ado-trastuzumab) that is not accompanied by chemotherapy is NOT
considered an eligible active treatment

- Patients on endocrine therapy alone are not eligible; OR

- Prior or current transplant for the treatment of cancer:

- Patient has received an allogenic stem cell/bone marrow 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 graft
versus (vs.) host disease; or

- Patient has received an autologous stem cell/bone marrow transplant within
the past 2 years

- Patient must have documented positive viral test result for SARS-CoV-2

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

- For patients under 18 years of age, the specimen collection for the patient's
first 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

- Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is
allowable for the viral SARS-CoV-2 test

- Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are
being tested again

- The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance
with the most recent guidance issued by the FDA in the Policy for Coronavirus
Disease-2019 Tests During the Public Health Emergency. This policy is available
at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-c
oronavirus-disease-2019-tests-during-public-health-emergency-revised

- 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

- PEDIATRIC COVNET COHORT ELIGIBILITY CRITERIA:

Patients should only be enrolled in the pediatric COVNET cohort if they are not eligible
for the main NCCAPS Study cohort or decline to participate in the main study

- Patient must be < 18 years of age

- Patient must have a positive SARS-CoV-2 viral test after January 31, 2020

- Patient must have a current or prior diagnosis of cancer. Active cancer treatment is
not required

- Note: Patients who enroll on Pediatric COVNET cohort will not be followed
longitudinally; study data collection involves only a single questionnaire and
research blood collection. A separate consent document is provided for the Pediatric
COVNET cohort

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 names:
    • Biological Sample Collection
  • 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

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Site Public Contact
800-811-8480

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 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 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.