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Trial record 1 of 1 for:    NCT04387656
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NCI COVID-19 in Cancer Patients, NCCAPS Study

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ClinicalTrials.gov Identifier: NCT04387656
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment
Asymptomatic COVID-19 Infection Laboratory-Confirmed Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed Procedure: Biospecimen Collection Other: Data Collection

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 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Group/Cohort Intervention/treatment
Observational (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 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.
Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Data Collection
Undergo collection of medical information and imaging




Primary Outcome Measures :
  1. Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity [ Time Frame: Up to 2 years ]
    Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit [ICU] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.

  2. Effects of COVID-19 on cancer therapy and association with clinical outcomes [ Time Frame: Up to 2 years ]
    Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for subgroups of patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.


Other Outcome Measures:
  1. Collection of blood specimens for future biomarker studies [ Time Frame: Up to 2 years ]
    Analysis will include time to development of antibodies, prevalence of cytokine abnormalities, and genome-wide association study (GWAS) to define genetic polymorphisms associated with severe COVID-19 disease/mortality.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a prior or current cancer diagnosis and with a positive SARS CoV-2 test within 14 days of enrollment
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) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387656


Locations
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Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Larissa A Korde National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04387656    
Other Study ID Numbers: NCI-2020-02986
NCI-2020-02986 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCICOVID ( Other Identifier: National Cancer Institute )
NCICOVID ( Other Identifier: CTEP )
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute (NCI):
COVID-19
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Laboratory Infection
Neoplasms
Occupational Diseases