NCI COVID-19 in Cancer Patients NCCAPS Study

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    National Cancer Institute (NCI)
Updated on 19 February 2024
cancer
HIV Infection
metastasis
solid tumor
hormone therapy
monoclonal antibodies
targeted therapy
endocrine therapy
antibody test
stem cell transplantation
rituximab
bone marrow transplant
hematologic malignancy
monoclonal antibody therapy
trastuzumab
cancer treatment
pertuzumab
cetuximab
coronavirus
active treatment
cancer diagnosis
immunodeficiency
covid-19
nucleic acid
cancer therapy
seizure
solid neoplasm
bone marrow procedure
oropharyngeal
mek inhibitor
cellular therapy
cns metastases
antibody therapy
stem cell transplant
coronavirus infection
nasopharyngeal swab
antigen test
metastatic cancer
malignant solid neoplasm
biospecimen collection
radionuclide therapy
acute respiratory syndrome (sars)
BRAF
viral test
antibody tests
targeted radionuclide therapy
radiation therapy, targeted
hematopoietic and lymphoid cell neoplasm

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.

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 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:

I. 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.

Details
Condition Hematologic Malignancy, hematologic neoplasms, hematologic neoplasms, Malignant Solid Neoplasm, Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Age 18years - 100years
Treatment data collection, Biospecimen Collection
Clinical Study IdentifierNCT04387656
SponsorNational Cancer Institute (NCI)
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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