This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).
Subject is 18 years of age or older;
Subject is willing to provide written informed consent;
Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either;
residual tumor tissue available for testing by the Sponsor; or
Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit.
Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit.
Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up).
Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
Male or female patients at least 18 years of age who have been diagnosed with non-hematologic cancer (Stages I-IV) and who meet all study inclusion criteria and no exclusion criteria. Primarily subjects with breast, colorectal, lung, or melanoma cancer (90%) will be enrolled. The remaining subjects (10%) diagnosed with other cancer types may be enrolled on a case by case basis.
Case-only
Prospective
Not listed
biospecimen sample collection for liquid biopsy assay development
Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer.
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