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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Trial Status: active
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 four cancer types (breast, colorectal,
lung, prostate). These cancers were selected based on the existing clinical landscape and
treatment availability.
Inclusion Criteria
Newly diagnosed (within 90 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
Additional locations may be listed on ClinicalTrials.gov for NCT05366881.
