cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
NCT05366881 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 7000
Last updated 2026-01-20
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 lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Conditions
- Brain Cancer
- Breast Cancer
- Bladder Cancer
- Cervical Cancer
- Colorectal Cancer
- Endometrial Cancer
- Esophageal Cancer
- Stomach Cancer
- Head and Neck Cancer
- Hepatobiliary Cancer
- Leukemia
- Lung Cancer
- Lymphoma
- Multiple Myeloma
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Renal Cancer
- Sarcoma
- Thyroid Cancer
Sponsors & Collaborators
-
Adela, Inc
lead INDUSTRY
Principal Investigators
-
Brian Rini, MD · Vanderbilt-Ingram Cancer Center
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-05-03
- Primary Completion
- 2026-03-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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