Active — Not RecruitingNot Applicable

NCI COVID-19 in Cancer Patients, NCCAPS Study

United States, Canada, Puerto Rico1,877 participantsStarted 2020-06-05

Plain-language 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

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, nerat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study seems to be observational — tracking what happens to cancer patients who get COVID-19 rather than testing a new treatment — so does joining it mean anything would change about my actual cancer care or COVID-19 treatment?
2Since the trial is no longer enrolling new patients, is there any way I could still participate, or is there a similar active study I should know about that's looking at how COVID-19 affects people with my type of cancer?
3One of the things this study tracks is how COVID-19 affects cancer therapy and outcomes — given my specific cancer and current treatment plan, how concerned should I be about the risk of COVID-19 disrupting or delaying my care?
4The study also collects patient-reported quality of life data — if I had participated, how would that information have been used, and are there other ways my experiences with COVID-19 and cancer could still contribute to research?
5Given what researchers have learned so far from studies like this one about COVID-19 severity in cancer patients, are there specific precautions or monitoring steps you'd recommend for me based on my diagnosis and treatment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity

Timeframe: Up to 2 years

Effects of COVID-19 on cancer therapy and association with clinical outcomes

Timeframe: Up to 2 years

Physical health (patient-reported health-related quality of life)

Timeframe: Up to 2 years

Trial details

NCT IDNCT04387656

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2024-03-20

View on ClinicalTrials.gov More COVID-19 Infection trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity

Timeframe: Up to 2 years

Effects of COVID-19 on cancer therapy and association with clinical outcomes

Timeframe: Up to 2 years

Physical health (patient-reported health-related quality of life)

Timeframe: Up to 2 years