Adela, Inc
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.
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
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.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 7000 participants |
| Official Title : | cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse |
| Actual Study Start Date : | 2022-05-03 |
| Estimated Primary Completion Date : | 2025-09 |
| Estimated Study Completion Date : | 2026-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
City of Hope
Duarte, California, United States, 91010
RECRUITING
Miami Cancer Institute
Miami, Florida, United States, 33176
RECRUITING
North Georgia Health System
Gainesville, Georgia, United States, 306501
RECRUITING
Baptist Floyd
New Albany, Indiana, United States, 47150
RECRUITING
Baptist Corbin
Corbin, Kentucky, United States, 40701
RECRUITING
Baptist Hardin
Elizabethtown, Kentucky, United States, 42701
RECRUITING
Baptist Lexington
Lexington, Kentucky, United States, 40503
WITHDRAWN
Baptist Paducah
Paducah, Kentucky, United States, 42003
RECRUITING
Mayo Clinic
Rochester, Minnesota, United States, 55902
RECRUITING
Cleveland Clinic
Cleveland, Ohio, United States, 44195
RECRUITING
Oregon Health Sciences University
Portland, Oregon, United States, 97201
RECRUITING
McLeod Health
Florence, South Carolina, United States, 29502
RECRUITING
Baptist (BHMCC)
Memphis, Tennessee, United States, 38120
RECRUITING
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37203
RECRUITING
Elligo Health Research, Inc.
Austin, Texas, United States, 78704