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

Plain English Summary

NCI COVID-19 in Cancer Patients, NCCAPS Study is a Not Applicable clinical trial sponsored by National Cancer Institute (NCI) studying COVID-19 Infection, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm. This study observes how COVID-19 affects cancer patients undergoing treatment. It is for individuals diagnosed with cancer who have tested positive for COVID-19. Participation involves providing blood samples, medical information, and images, and completing questionnaires. There are no alternative treatments offered within this study; it is observational. The trial aims to enroll 1877 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have a current or past cancer diagnosis and have tested positive for COVID-19. You may not be eligible if you have certain types of cancer or are receiving specific treatments not covered by the study. The study is open to patients aged 18 and older, and a separate cohort is available for those under 18. You must have a positive viral test for COVID-19 (PCR or antigen test), not an antibody test. This trial is studying COVID-19 Infection, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how factors related to patients and their cancer influence the severity of COVID-19, how COVID-19 impacts cancer treatment effectiveness, and how patients feel physically The specific primary outcome measures are: Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity (Up to 2 years); Effects of COVID-19 on cancer therapy and association with clinical outcomes (Up to 2 years); Physical health (patient-reported health-related quality of life) (Up to 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This study is important because it helps researchers understand the complex interactions between COVID-19 and cancer, filling a critical knowledge gap for vulnerable patients. This research targets COVID-19 Infection, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, where improved treatment options are needed.

Investor Insight

This observational study by the NCI provides valuable real-world data on a critical intersection of diseases, informing future treatment strategies and potentially impacting the management of cancer p The large enrollment target of 1877 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your specific cancer type and treatment plan make you eligible for this study. Be prepared to provide medical records, undergo blood draws, and complete surveys about your health and quality of life over time. The study aims to collect data over a period of up to two years. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 1,877 participants

Interventions

• PROCEDURE: Biospecimen Collection — Undergo collection of blood samples
• OTHER: Data Collection — Undergo collection of medical information and imaging
• OTHER: Quality-of-Life Assessment — Complete quality of life questionnaires
• OTHER: Questionnaire Administration — Complete quality of life questionnaires

Primary Outcomes

• Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity (Up to 2 years)
• Effects of COVID-19 on cancer therapy and association with clinical outcomes (Up to 2 years)
• Physical health (patient-reported health-related quality of life) (Up to 2 years)

Full Eligibility 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 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-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

Trial Locations

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• Veterans Administration Medical Center - Birmingham, Birmingham, Alabama, United States
• USA Health Strada Patient Care Center, Mobile, Alabama, United States
• Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
• Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
• Alaska Women's Cancer Care, Anchorage, Alaska, United States
• Anchorage Oncology Centre, Anchorage, Alaska, United States
• Katmai Oncology Group, Anchorage, Alaska, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• COVID-19 Infection
• Lung Cancer
• Breast Cancer
• Prostate Cancer
• Leukemia
• Lymphoma
• Multiple Myeloma
• Pancreatic Cancer
• Colorectal Cancer
• Gastrointestinal Cancers

More COVID-19 Infection Trials

View all COVID-19 Infection clinical trials