What this study is
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.
Study details
- Official title
- cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
- Sponsor
- Adela, Inc
- 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
- Enrolling
- 7,000 people
- Starts
- 2022-05-03
- Est. completion
- 2027-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers AcceptedCase
You may qualify if
- 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
You can't join if
- 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
You may qualify if
- 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
You can't join if
- Currently receiving any treatment for cancer
- Currently taking any demethylating agents/DNA hypomethylating agents
- Women who are known to be pregnant (self-reported)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (17)
3 openCity of Hope
Duarte, California, United States
- Xiao-Yu Xia · Contact626-218-0630xxia@coh.org
- Gregory Idos, MD · Principal investigator
RecruitingOregon Health Sciences University
Portland, Oregon, United States
- Diana Potts · Contactpottsd@ohsu.edu
- Nima Nabavizadeh, MD · Principal investigator
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
- Michael Balassone · Contact843-792-6696balassom@musc.edu
- Andrew M Chen · Contactchenand@musc.edu
- Gerard Silvestri, MD · Principal investigator
RecruitingMiami Cancer Institute
Miami, Florida, United States
CompletedNorth Georgia Health System
Gainesville, Georgia, United States
CompletedBaptist Floyd
New Albany, Indiana, United States
CompletedBaptist Corbin
Corbin, Kentucky, United States
CompletedBaptist Hardin
Elizabethtown, Kentucky, United States
CompletedBaptist Lexington
Lexington, Kentucky, United States
CompletedBaptist Paducah
Paducah, Kentucky, United States
WithdrawnAllina Health Cancer Institute
Minneapolis, Minnesota, United States
CompletedMayo Clinic
Rochester, Minnesota, United States
CompletedCleveland Clinic
Cleveland, Ohio, United States
CompletedMcLeod Health
Florence, South Carolina, United States
CompletedBaptist (BHMCC)
Memphis, Tennessee, United States
CompletedVanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
CompletedElligo Health Research, Inc.
Austin, Texas, United States
Completed
Study team
Sponsor
Adela, Inc
Study ID Adela-EDMRD-001
Principal investigator
Brian Rini, MD
Vanderbilt-Ingram Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.