Abstract
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Objectives: In order to observe the biologic effects of COVID-19 as a rising co-morbidity in cancer patients, the NCI initiated a natural history clinical trial (NCI-COVID) via its National Clinical Trial Network and its National Community Oncology Research Program. Clinical data, bio specimens, CT, MRI and PET/CT imaging performed as part of clinical care within the initial 6 months after COVID-19 diagnosis are being collected to assess the impact of COVID-19 on cancer lesions, such as flare or accelerated progression, and to determine the potential diagnostic difficulties in evaluating cancer burden due to residual abnormalities from COVID-19.
Methods: Images collected pre-COVID infection are being used as reference. COVID-19 management-related imaging which document organ involvement and complications is being collected via the NCI Imaging and Radiation Oncology Core. Radiological findings prevalent among the first 300 patients will be used to develop the analysis plan. Radiological findings on patient subgroups will investigate the relationship of cancers and COVID-19. While less than 2% of COVID-19 infections occur in pediatrics, we will attempt to collect from pediatric patients.
Results: At the end of the calendar year 2020, 760 patients were enrolled in the trial, of which 262 had submitted imaging data. Of this imaging data, 63 were PET/CT studies, 51 performed prior to COVID-19 infection, 3 during active infection, and 9 post-infection. At that time, five patients had repeated imaging, 1 of which was a scan performed during infection 3 months after the reference, pre-infection scan, the other 4 of which were post-infection, within 3-6 months of the pre-infection imaging. The most recent information shareable will be presented just in time at SNMMI 2021, along with the reporting of any challenges or learning points from the organization of such a study. At that timepoint, information will also be provided on how limited imaging data may be made available and timelines of the NCI The Cancer Imaging Archive.
Conclusions: This update provides current status of experience, organization and assessment plans of the NCI-NCTN Clinical Trial: Natural History of COVID-19 in Cancer Patients Research Support: NCT04387656 Grant