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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 : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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

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Study Design
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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
Groups and Cohorts
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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 Name: Biological Sample Collection

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


Outcome Measures
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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

Eligibility Criteria
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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:   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:

  • 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-coronavirus-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
Contacts and Locations
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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)
More Information
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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: July 30, 2021
Last Verified: April 2021
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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Neoplasms