cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.

Case Inclusion Criteria: * Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed \>5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma * Able and willing to provide informed consent * ≥40 years of age Case Exclusion Criteria: * Currently receiving any treatment for cancer * Currently taking any demethylating agents/DNA hypomethylating agents * Simultaneously diagnosed with two or more invasive cancers * Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years * Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer * Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer * Women who are known to be pregnant (self-reported) Control Inclusion Criteria * Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed) * Able and willing to provide informed consent * ≥40 years of age Control Exclusion Criteria * Currently receiving any treatment for cancer * Currently taking any demethylating agents/DNA hypomethylating agents * Women who are known to be pregnant (self-reported)