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Clinical Trial 20763

Cancer Type: Malignant Hematology
Study Type: Other
NCT#: NCT04387656

Phase: N/A
Prinicipal Investigator:

Call 813-745-6100
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Overview

Study Title

NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

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.

Objective

Primary Objectives 1.1.1 Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 1.1.2 Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 1.1.3 Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

  • STEP 0 ELIGIBILITY CRITERIA:
  • 18 years of age or older
  • 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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