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NCI COVID-19 in Cancer Patients, NCCAPS Study

About

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.

Study Type
Observational
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
N/A

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-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

Join this Trial

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Study Stats
Protocol No.
20-001308
Category
Obstetrics & Gynecology
Oncology
Other
Contact
Jenny Lester
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04387656
For detailed technical eligibility, visit ClinicalTrials.gov.