GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop
assays to detect cancer early in blood. The purpose of this study is to collect
biological samples from participants with a new diagnosis of cancer (blood and tumor
tissue) and from participants who do not have a diagnosis of cancer (blood) in order to
characterize the population heterogeneity in cancer and non-cancer participants and to
develop models for distinguishing cancer from non-cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02889978.
This is a prospective, multi-center, observational study with collection of de-identified
biospecimens and clinical data from at least 15,000 participants from clinical networks
in the United States and Canada. The study will enroll approximately 10,500 cancer
participants (CANCER arm) and approximately 4,500 representative participants without a
clinical diagnosis of cancer (NON-CANCER arm). Clinical information, demographics, and
medical data relevant to cancer status are collected from all participants and their
medical record at baseline (time of biospecimen collection), and subsequently from the
medical record at intermittent future time points, at least annually for up to 5 years.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationGrail Bio