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

Status
Active
Cancer Type
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCT ID
NCT04387656
Protocol IDs
NCICOVID (primary)
NCICOVID
NCI-2020-02986
Study Sponsor
National Cancer Institute

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.

Objectives

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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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