Breast Cancer Clinical Trial
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Summary
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.
Full Description
This is an observational case-control study that includes individuals with cancer and individuals without known cancer. All participants will have clinical follow-up after enrollment. A subset of individuals with cancer will also have longitudinal blood sampling to evaluate the ability of the genome-wide methylome enrichment platform to detect minimal residual disease. This includes individuals with Stage I-III breast, colorectal, lung, or prostate cancer (Tier 1 Cancers).
At baseline, all participants will provide a blood sample and applicable clinical data.
Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the completion of first-line treatment, every 3 months for the first year after first-line treatment, and every 6 months for an additional 2 years. All other cases will have clinical follow-up once a year for 3 years after enrollment.
Control participants will have clinical follow-up every 6 months for up to 3 years from enrollment to evaluate cancer status.
The blood test to be used in this study is a highly sensitive, epigenomic-based genome-wide methylome enrichment platform. The assay includes bisulfite-free, non-degradative genome-wide DNA methylation profiling from small quantities of cell-free DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and preserve the native fragment length. This is followed by high throughput sequencing.
For all assays, samples from participants with cancer and participants without cancer will be run together to reduce batch effects using methodology determined by the Sponsor. Results from the liquid biopsy test will not be returned to clinicians or participants.
Eligibility Criteria
Case 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 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)
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There are 15 Locations for this study
Duarte California, 91010, United States More Info
Principal Investigator
Miami Florida, 33176, United States More Info
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Gainesville Georgia, 30650, United States More Info
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New Albany Indiana, 47150, United States More Info
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Corbin Kentucky, 40701, United States More Info
Principal Investigator
Elizabethtown Kentucky, 42701, United States More Info
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Lexington Kentucky, 40503, United States More Info
Principal Investigator
Paducah Kentucky, 42003, United States More Info
Principal Investigator
Rochester Minnesota, 55902, United States More Info
Principal Investigator
Cleveland Ohio, 44195, United States More Info
Principal Investigator
Portland Oregon, 97201, United States More Info
Principal Investigator
Florence South Carolina, 29502, United States More Info
Principal Investigator
Memphis Tennessee, 38120, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Austin Texas, 78704, United States More Info
Principal Investigator
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