Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

NCI COVID-19 in Cancer Patients, NCCAPS Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387656
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : March 1, 2021
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
COVID-19 Infection Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Procedure: Biospecimen Collection Other: Data Collection Other: Quality-of-Life Assessment Other: Questionnaire Administration

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.

Layout table for study information
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 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete quality of life questionnaires




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 pediatric patients and subgroups of adult 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.

  3. Physical health (patient-reported health-related quality of life) [ Time Frame: Up to 2 years ]
    Will be measured using items from the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile.


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.


Layout table for eligibility information
Ages Eligible for Study:   Child, 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) 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-use-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.

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
Show Show 885 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Larissa A Korde National Cancer Institute (NCI)
Layout table for additonal information
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: March 1, 2021
Last Verified: December 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

Layout table for additional information
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:
Layout table for MeSH terms
Neoplasms