NCT04387656

NCI COVID-19 in Cancer Patients, NCCAPS Study

Official Title:

NCI COVID-19 in Cancer Patients Study (NCCAPS): 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.

Eligibility

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 (polymerase chain reaction \[PCR\]) 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 Food and Drug administration (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-document…
* 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

Disease(s) and\or Condition(s)

COVID-19 Infection

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Primary Purpose
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Biospecimen Collection
    • Description: Undergo collection of blood samples
    • Arm Group Labels: Observational Cohort (data collection, biospecimen collection)
    • Type: OTHER
    • Name: Data Collection
    • Description: Undergo collection of medical information and imaging
    • Arm Group Labels: Observational Cohort (data collection, biospecimen collection)
    • Type: OTHER
    • Name: Quality-of-Life Assessment
    • Description: Complete quality of life questionnaires
    • Arm Group Labels: Observational Cohort (data collection, biospecimen collection)
    • Type: OTHER
    • Name: Questionnaire Administration
    • Description: Complete quality of life questionnaires
    • Arm Group Labels: Observational Cohort (data collection, biospecimen collection)
Sponsor
  • National Cancer Institute (NCI)