CLINICAL TRIAL / NCT04387656
NCI COVID-19 in Cancer Patients, NCCAPS Study
- Observational
- Recruiting
- NCT04387656
Contact Information
NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study
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.
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.
Gender
All
Age Group
Any
Accepting Healthy Volunteers
No
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 (polymerase chain reaction [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 Food and Drug administration (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