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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.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
South Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not Available
Tennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Temporarily closed to accrual
Name Not Available
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.
