NCI COVID-19 in Cancer Patients NCCAPS Study

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    2000
  • sponsor
    National Cancer Institute (NCI)
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Updated on 18 January 2021
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Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (7.7 mi away) Contact
+689 other location
cancer
bone marrow transplant
rituximab
monoclonal antibodies
cancer treatment
solid tumor
antibody therapy

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.

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.

Details
Treatment questionnaire administration, quality-of-life assessment, Data Collection, biospecimen collection
Clinical Study IdentifierNCT04387656
SponsorNational Cancer Institute (NCI)
Last Modified on18 January 2021

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Eligibility

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Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Blood Cancer or Asymptomatic COVID-19 Infection Laboratory-Confirmed or Symptomatic COVID-19 Infection Laboratory-Confirmed or Malignant Solid Neoplas...?
Do you have any of these conditions: Hematologic Neoplasms or Covid 19 Infection or Hematologic Malignancy or Malignant Solid Tumor or hematopoietic and lymphoid cell neoplasm or Symptoma...?
Do you have any of these conditions: COVID-19 Infection or hematopoietic and lymphoid cell neoplasm or Covid 19 Infection or Asymptomatic COVID-19 Infection Laboratory-Confirmed or Blood ...?
Do you have any of these conditions: hematopoietic malignancy or Malignant Solid Neoplasm or metastatic malignant solid tumor or Malignant Solid Tumor or Hematologic Neoplasms or hematopo...?
Do you have any of these conditions: Metastatic Solid Tumor or Malignant Solid Neoplasm or Asymptomatic COVID-19 Infection Laboratory-Confirmed or Hematologic Malignancy or Metastatic Mal...?
Do you have any of these conditions: Metastatic Solid Tumor or Symptomatic COVID-19 Infection Laboratory-Confirmed or hematopoietic malignancy or metastatic malignant solid tumor or Hemat...?
Do you have any of these conditions: Hematologic Malignancy or Malignant Solid Tumor or Blood Cancer or Symptomatic COVID-19 Infection Laboratory-Confirmed or Asymptomatic COVID-19 Infect...?
Do you have any of these conditions: Symptomatic COVID-19 Infection Laboratory-Confirmed or Metastatic Solid Tumor or Blood Cancer or Hematologic Cancer or Hematologic Neoplasms or metast...?
Do you have any of these conditions: Covid 19 Infection or COVID-19 Infection or Metastatic Malignant Solid Neoplasm or Blood Cancer or Malignant Solid Neoplasm or Malignant Solid Tumor o...?
Do you have any of these conditions: Hematologic Malignancy or Hematologic Cancer or Asymptomatic COVID-19 Infection Laboratory-Confirmed or Covid 19 Infection or Symptomatic COVID-19 Inf...?
Do you have any of these conditions: Hematologic Malignancy or Blood Cancer or Hematologic Neoplasms or COVID-19 Infection or Metastatic Malignant Solid Neoplasm or Metastatic Solid Tumor...?
Do you have any of these conditions: Symptomatic COVID-19 Infection Laboratory-Confirmed or COVID-19 Infection or Asymptomatic COVID-19 Infection Laboratory-Confirmed or Covid 19 Infectio...?
Do you have any of these conditions: Blood Cancer or Asymptomatic COVID-19 Infection Laboratory-Confirmed or Malignant Solid Neoplasm or Symptomatic COVID-19 Infection Laboratory-Confirme...?
Do you have any of these conditions: Asymptomatic COVID-19 Infection Laboratory-Confirmed or metastatic malignant solid tumor or Hematologic Neoplasms or Hematologic Malignancy or Symptom...?
Do you have any of these conditions: Hematologic Malignancy or Malignant Solid Neoplasm or Metastatic Malignant Solid Neoplasm or COVID-19 Infection or hematopoietic malignancy or Hematol...?
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-u> se-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
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