cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

Part of paid clinical trials in Duarte, California.

Sponsor
Adela, Inc
Study ID
NCT05366881
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
May 3, 2022
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
7,000 participants (estimated)

Arms

  • Arm: Cases
    Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.
  • Arm: Controls
    Controls will include participants without known cancer at the time of enrollment.

Primary Outcome Measure

Detection of cancer [ Time Frame: 24 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Xiao-Yu Xia
[email protected]
626-218-0630
Gregory Idos, MD (PRINCIPAL_INVESTIGATOR)
Miami Cancer InstituteMiamiFlorida33176
Belkys Salinas
[email protected]
Manmeet Ahluwalia, MD (PRINCIPAL_INVESTIGATOR)
North Georgia Health SystemGainesvilleGeorgia306501
Charles Nash, MD (PRINCIPAL_INVESTIGATOR)
Baptist FloydNew AlbanyIndiana47150
Tasha Dodson
[email protected]
Amitoj Gill, MD (PRINCIPAL_INVESTIGATOR)
Baptist CorbinCorbinKentucky40701
Abigail Byrnes, MD (PRINCIPAL_INVESTIGATOR)
Baptist HardinElizabethtownKentucky42701
Christopher Burkeen, MD (PRINCIPAL_INVESTIGATOR)
Baptist LexingtonLexingtonKentucky40503
Arvinda Padmanabhan, MD (PRINCIPAL_INVESTIGATOR)
Baptist PaducahPaducahKentucky42003-
Allina Health Cancer InstituteMinneapolisMinnesota55407
Jonathon Alexander
[email protected]
612-863-8625
Jennie Schletty
[email protected]
612-863-8625
Joleen Hubbard, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55902
Angela R Emanuel
[email protected]
Lisa A Boardman, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Mofetoluwa Oluwasanmi
[email protected]
216-444-0843
Peter Mazzone, MD, MPH (PRINCIPAL_INVESTIGATOR)
Oregon Health Sciences UniversityPortlandOregon97201
Nima Nabavizadeh, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Michael Balassone
[email protected]
843-792-6696
Andrew M Chen
[email protected]
Gerard Silvestri, MD (PRINCIPAL_INVESTIGATOR)
McLeod HealthFlorenceSouth Carolina29502
Betsy Harris
[email protected]
Virginia Clyburn-Ipock, MD (PRINCIPAL_INVESTIGATOR)
Baptist (BHMCC)MemphisTennessee38120
Tracy Stewart
[email protected]
Philip Lammers, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37203
Brian Rini, MD (PRINCIPAL_INVESTIGATOR)
Elligo Health Research, Inc.AustinTexas78704
Cynthia Currasco
[email protected]
Faith Holmes, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Bladder cancerBrain cancerBreast cancerCervical cancerColorectal cancerEndometrial cancerEsophageal cancerHead and neck cancerLeukemia (other)Lung cancerMultiple myelomaOvarian cancerPancreatic cancerProstate cancerKidney cancerGastric cancer
By specialty
OncologyUrologyNeuro-oncologyBreast oncologyWomen's healthGynecologic oncologyGI oncologyENTBlood cancerLung oncologyLung diseaseProstate oncologyMen's health
By research site
City of Hope· Duarte, CAMiami Cancer Institute· Miami, FLNorth Georgia Health System· Gainesville, GABaptist Floyd· New Albany, INBaptist Corbin· Corbin, KYBaptist Hardin· Elizabethtown, KY

Related Studies