NCI COVID-19 in Cancer Patients NCCAPS Study
-
- STATUS
- Recruiting
-
- participants needed
- 2000
-
- sponsor
- National Cancer Institute (NCI)
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 severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19), including severity and fatality, in cancer patients undergoing treatment.
II. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation.
III. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.
CORRELATIVE OBJECTIVES:
I. Future correlative biomarker objectives will include assessment of the development of SARS coronavirus 2 (SARS CoV-2) antibodies, description of the trajectory of cytokine abnormalities, and genome-wide association studies to define polymorphisms associated with severe COVID-19.
II. Future correlative imaging objectives will include assessment of COVID-19 sequelae in cancer patients.
III. Collection and banking of research blood specimens and radiological images for future research.
- 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 up to 9 times at the same times they receive routine bloodwork. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times.
Details
| Condition | Hematologic Malignancy, hematologic neoplasms, hematologic neoplasms, Malignant Solid Neoplasm, Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed |
|---|---|
| Age | 18years - 100years |
| Treatment | data collection, Biospecimen Collection |
| Clinical Study Identifier | NCT04387656 |
| Sponsor | National Cancer Institute (NCI) |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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