cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Recruiting · NCT05366881 · Observational (researchers observe without assigning treatment) · Lead sponsor: Adela, Inc
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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)
Where it is running
17 locations listed across 11 US states.
- City of Hope - Duarte, California, United States
- Miami Cancer Institute - Miami, Florida, United States
- North Georgia Health System - Gainesville, Georgia, United States
- Baptist Floyd - New Albany, Indiana, United States
- Baptist Corbin - Corbin, Kentucky, United States
- Baptist Hardin - Elizabethtown, Kentucky, United States
- Baptist Lexington - Lexington, Kentucky, United States
- Baptist Paducah - Paducah, Kentucky, United States
- Allina Health Cancer Institute - Minneapolis, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Oregon Health Sciences University - Portland, Oregon, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- McLeod Health - Florence, South Carolina, United States
- Baptist (BHMCC) - Memphis, Tennessee, United States
- Vanderbilt-Ingram Cancer Center - Nashville, Tennessee, United States
- Elligo Health Research, Inc. - Austin, Texas, United States