The Circulating Cell-free Genome Atlas Study
- Conditions
- NeoplasmsCancer
- Registration Number
- NCT02889978
- Lead Sponsor
- GRAIL, Inc.
- Brief Summary
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from participants with a new diagnosis of cancer (blood and tumor tissue) and from participants who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer participants and to develop models for distinguishing cancer from non-cancer.
- Detailed Description
This is a prospective, multi-center, observational study with collection of de-identified biospecimens and clinical data from at least 15,000 participants from clinical networks in the United States and Canada. The study will enroll approximately 10,500 cancer participants (CANCER arm) and approximately 4,500 representative participants without a clinical diagnosis of cancer (NON-CANCER arm). Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (time of biospecimen collection), and subsequently from the medical record at intermittent future time points, at least annually for up to 5 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15254
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect and study clinically-annotated biospecimens, specifically peripheral blood and contemporary tumor tissue when available, to characterize cfNA profiles from deep sequencing and to estimate the population heterogeneity in two arms of the study. 30 months To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. 30 months To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject. 30 months
- Secondary Outcome Measures
Name Time Method To explore the relationship between genomic results and clinical outcomes based on collection of longitudinal information (at least annually for up to 5 years) from medical records for all consenting participants. Year 1, 2, 3, 4, 5 To enable assessment of the performance of an analytically validated clinical laboratory version of the NGS assay (under development) to detect circulating tumor DNA (ctDNA) in plasma. Year 1, 2, 3, 4, 5
Trial Locations
- Locations (110)
Southern Cancer Center, P.C. - Mobile Infirmary
🇺🇸Mobile, Alabama, United States
Southern Cancer Center, PC - Mobile Airport
🇺🇸Mobile, Alabama, United States
Mercy Fort Smith
🇺🇸Fort Smith, Arkansas, United States
Sansum Clinic - 540
🇺🇸Santa Barbara, California, United States
Sansum Clinic- 317
🇺🇸Santa Barbara, California, United States
Rocky Mountain Cancer Center
🇺🇸Pueblo, Colorado, United States
Hartford HealthCare Cancer Institute at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Hartford New Britain
🇺🇸New Britain, Connecticut, United States
University of Miami Sylvester at Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
University of Miami Sylvester at Hollywood
🇺🇸Hollywood, Florida, United States
University of Miami Sylvester at Plantation
🇺🇸Plantation, Florida, United States
Minnesota Oncology Hematology, P.A. - Coon Rapids
🇺🇸Woodbury, Minnesota, United States
Mercy Joplin
🇺🇸Joplin, Missouri, United States
Mercy Research - Springfield
🇺🇸Springfield, Missouri, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Spartanburg Regional Healthcare System
🇺🇸Spartanburg, South Carolina, United States
Texas Oncology - Dallas Forest Ln
🇺🇸Dallas, Texas, United States
Tennessee Oncology Medical Park II
🇺🇸Chattanooga, Tennessee, United States
Tennessee Oncology Memorial Plaza
🇺🇸Chattanooga, Tennessee, United States
TXO - Methodist Dallas Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology-The Woodlands
🇺🇸The Woodlands, Texas, United States
UHN Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Oncology Hematology Care, Inc. - Reading Road
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc. - Fairfield
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc. - E. Galbraith
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc. - Malsbary
🇺🇸Cincinnati, Ohio, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
Minnesota Oncology Hematology, P.A. - Woodbury
🇺🇸Minneapolis, Minnesota, United States
Tennessee Oncology Midtown
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology Nashville
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology SCCBC
🇺🇸Nashville, Tennessee, United States
Texas Oncology - San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Texas Oncology-San Antonio Stone Oak
🇺🇸San Antonio, Texas, United States
Tennessee Oncology St. Thomas West
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology Skyline
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology Southern Hills
🇺🇸Nashville, Tennessee, United States
Texas Oncology-San Antonio Downtown
🇺🇸San Antonio, Texas, United States
Texas Oncology-San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
Oregon Health & Science University Knight Cancer Institute
🇺🇸Portland, Oregon, United States
Texas Oncology-Fort Worth
🇺🇸Fort Worth, Texas, United States
Texas Oncology-Southwest Fort Worth
🇺🇸Fort Worth, Texas, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Southern Cancer Center, PC - Daphne
🇺🇸Daphne, Alabama, United States
Southern Cancer Center, PC - Springhill Medical Center
🇺🇸Mobile, Alabama, United States
Sansum Clinic - Viborg
🇺🇸Solvang, California, United States
Rocky Mountain Cancer Centers
🇺🇸Thornton, Colorado, United States
UMHC Lennar Foundation - Coral Gables
🇺🇸Coral Gables, Florida, United States
Mayo Clinic - Florida
🇺🇸Jacksonville, Florida, United States
Florida Cancer Affiliates - Ocala
🇺🇸Ocala, Florida, United States
Woodlands Medical Specialists, PA
🇺🇸Pensacola, Florida, United States
UMHC Sylvester- Coral Springs
🇺🇸Coral Springs, Florida, United States
University of Miami Sylvester at Kendall
🇺🇸Kendall, Florida, United States
Memorial Sloan Kettering - Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Minnesota Oncology Hematology, P.A. - Main
🇺🇸Coon Rapids, Minnesota, United States
Christ Hospital Health Network - The Lindner Center Cancer Research Division
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc. - Mercy Health
🇺🇸Cincinnati, Ohio, United States
Baptist Health Louisville
🇺🇸Louisville, Kentucky, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Lahey Hospital & Medical Center - Peabody
🇺🇸Peabody, Massachusetts, United States
Baptist Health Paducah
🇺🇸Paducah, Kentucky, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Maryland Oncology Hematology, P.A.
🇺🇸Silver Spring, Maryland, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Memorial Sloan Kettering, NY - Monmouth
🇺🇸Middletown, New Jersey, United States
New York Oncology Hematology, P.C.
🇺🇸Clifton Park, New York, United States
Memorial Sloan Kettering - Rockville Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering, NY - Commack
🇺🇸New York, New York, United States
Memorial Sloan Kettering, NY - West Harrison
🇺🇸New York, New York, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States
Minnesota Oncology Hematology, P.A. - Edina
🇺🇸Edina, Minnesota, United States
Northwest Cancer Specialists, P.C. dba Compass Oncology
🇺🇸Vancouver, Washington, United States
Cancer Center at Lehigh Valley Hospital - Muhlenberg
🇺🇸Bethlehem, Pennsylvania, United States
Broome Oncology, LLC
🇺🇸Johnson City, New York, United States
Oncology Hematology Care, Inc. - Five Mile Road
🇺🇸Fairfield, Ohio, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Tennessee Oncology Summit
🇺🇸Hermitage, Tennessee, United States
Bon Secours Saint Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
Prisma Health - Upstate
🇺🇸Seneca, South Carolina, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Tennessee Oncology Cleveland Clinic
🇺🇸Cleveland, Tennessee, United States
Tennessee Oncology CMC
🇺🇸Crossville, Tennessee, United States
Tennessee Oncology Franklin
🇺🇸Franklin, Tennessee, United States
Tennessee Oncology Lebanon
🇺🇸Lebanon, Tennessee, United States
Tennessee Oncology Murfreesboro
🇺🇸Murfreesboro, Tennessee, United States
Tennessee Oncology Shelbyville
🇺🇸Shelbyville, Tennessee, United States
Tennessee Oncology Stonecrest
🇺🇸Smyrna, Tennessee, United States
Texas Oncology - West Texas
🇺🇸Wichita Falls, Texas, United States
Texas Oncology-Bedford
🇺🇸Bedford, Texas, United States
Tennessee Oncology Dickson
🇺🇸Dickson, Tennessee, United States
Tennessee Oncology Gallatin
🇺🇸Gallatin, Tennessee, United States
Texas Oncology - Presbyterian Cancer Center Dallas
🇺🇸Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
Texas Oncology - Mesquite
🇺🇸Mesquite, Texas, United States
Texas Oncology - Plano East
🇺🇸Plano, Texas, United States
Texas Oncology - Plano West
🇺🇸Plano, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Woodbridge, Virginia, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
Texas Oncology - Grapevine
🇺🇸Grapevine, Texas, United States
Texas Oncology Cancer Care and Research Center - Harlingen
🇺🇸Harlingen, Texas, United States
Texas Oncology - Longview Cancer Center
🇺🇸Longview, Texas, United States
Texas Oncology-New Braunfels
🇺🇸New Braunfels, Texas, United States
Texas Oncology - Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology - Weslaco
🇺🇸Weslaco, Texas, United States
Texas Oncology - Rockwall
🇺🇸Rockwall, Texas, United States