The Circulating Cell-free Genome Atlas Study
CCGA
1 other identifier
observational
15,254
2 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2016
CompletedFirst Submitted
Initial submission to the registry
August 18, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 13, 2023
September 1, 2023
7.6 years
August 18, 2016
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
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
Study Arms (2)
Cancer arm
Participants with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.
Non-cancer arm
Participants with no known diagnosis or past history of cancer from which a blood sample will be collected.
Eligibility Criteria
Eligible study participants will be recruited from participating medical centers in a ratio of 3 non-cancer participants for every 7 cancer participants within each individual research center. Non-cancer subject recruitment will be monitored to achieve demographic characteristics (eg, age, gender, ethnicity, smoking status) reflective of those of the cancer participants.
You may qualify if:
- Age 20 years or older
- Able to provide a written informed consent
You may not qualify if:
- Known current or prior diagnosis of cancer except non-melanoma skin cancer
- Oral or IV corticosteroid use in past 14 days prior to blood draw
- Pregnancy (by self-report)
- Current febrile illness
- Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
- Poor health status or unfit to tolerate blood draw
- Age 20 years or older
- Able to provide a written informed consent
- Have either of the following:
- A. Confirmed cancer diagnosis (any stage I-IV, as well as carcinoma in situ (CIS) within 90 days prior to or up to 42 days after study blood draw, based upon assessment of a pathological specimen
- B. A high suspicion for a cancer diagnosis by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw
- Known prior diagnosis of cancer except non-melanoma skin cancer
- Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy
- Pregnancy (by self-report)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GRAIL, Inc.lead
Study Sites (140)
Southern Cancer Center, PC - Daphne
Daphne, Alabama, 36526, United States
Southern Cancer Center, P.C. - Mobile Infirmary
Mobile, Alabama, 36607, United States
Southern Cancer Center, PC - Mobile Airport
Mobile, Alabama, 36608, United States
Southern Cancer Center, PC - Springhill Medical Center
Mobile, Alabama, 36608, United States
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
Mercy Fort Smith
Fort Smith, Arkansas, 72903, United States
Sansum Clinic - 540
Santa Barbara, California, 93105, United States
Sansum Clinic- 317
Santa Barbara, California, 93105, United States
Sansum Clinic - Viborg
Solvang, California, 93463, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Center
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers
Centennial, Colorado, 80112, United States
Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Center
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120-4413, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Center
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06102, United States
Hartford New Britain
New Britain, Connecticut, 06052, United States
UMHC Lennar Foundation - Coral Gables
Coral Gables, Florida, 33146, United States
UMHC Sylvester- Coral Springs
Coral Springs, Florida, 33065, United States
University of Miami Sylvester at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Sylvester at Hollywood
Hollywood, Florida, 33021, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
University of Miami Sylvester at Kendall
Kendall, Florida, 33176, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Florida Cancer Affiliates - Ocala
Ocala, Florida, 34471, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503, United States
University of Miami Sylvester at Plantation
Plantation, Florida, 33324, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Baptist Health Paducah
Paducah, Kentucky, 42003, United States
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology, P.A.
Clinton, Maryland, 20735, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Lahey Hospital & Medical Center - Peabody
Peabody, Massachusetts, 01960, United States
Minnesota Oncology Hematology, P.A. - Main
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A. - Edina
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology, P.A. - Woodbury
Minneapolis, Minnesota, 55404, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 32224, United States
Minnesota Oncology Hematology, P.A. - Coon Rapids
Woodbury, Minnesota, 55125, United States
Mercy Joplin
Joplin, Missouri, 64804, United States
Mercy Research - Springfield
Springfield, Missouri, 65804, United States
Memorial Sloan Kettering - Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering, NY - Monmouth
Middletown, New Jersey, 07748, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
Broome Oncology, LLC
Binghamton, New York, 13905, United States
New York Oncology Hematology, P.C.
Clifton Park, New York, 12065, United States
Broome Oncology, LLC
Johnson City, New York, 13790, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering - Rockville Center
New York, New York, 10065, United States
Memorial Sloan Kettering, NY - Commack
New York, New York, 10065, United States
Memorial Sloan Kettering, NY - West Harrison
New York, New York, 10065, United States
Memorial Sloan Kettering
New York, New York, 10065, United States
Oncology Hematology Care, Inc. - Reading Road
Cincinnati, Ohio, 45202, United States
Oncology Hematology Care, Inc. - Fairfield
Cincinnati, Ohio, 45211, United States
Christ Hospital Health Network - The Lindner Center Cancer Research Division
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care, Inc. - Mercy Health
Cincinnati, Ohio, 45230, United States
Oncology Hematology Care, Inc. - E. Galbraith
Cincinnati, Ohio, 45236, United States
Oncology Hematology Care, Inc. - Malsbary
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oncology Hematology Care, Inc. - Five Mile Road
Fairfield, Ohio, 45014, United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, 97201, United States
Northwest Cancer Specialists, P.C. dba Compass Oncology
Portland, Oregon, 97213-2982, United States
Northwest Cancer Specialists, P.C. dba Compass Oncology
Portland, Oregon, 97225, United States
Northwest Cancer Specialists, P.C. dba Compass Oncology
Portland, Oregon, 97227, United States
Northwest Cancer Specialists, P.C. dba Compass Oncology
Tualatin, Oregon, 97062, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18101, United States
Cancer Center at Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health - Upstate
Seneca, South Carolina, 29672, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Tennessee Oncology Medical Park II
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology Memorial Plaza
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology Cleveland Clinic
Cleveland, Tennessee, 37311, United States
Tennessee Oncology CMC
Crossville, Tennessee, 38555, United States
Tennessee Oncology Dickson
Dickson, Tennessee, 37055, United States
Tennessee Oncology Franklin
Franklin, Tennessee, 37067, United States
Tennessee Oncology Gallatin
Gallatin, Tennessee, 37066, United States
Tennessee Oncology Summit
Hermitage, Tennessee, 37076, United States
Tennessee Oncology Lebanon
Lebanon, Tennessee, 37090, United States
Tennessee Oncology Murfreesboro
Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology Midtown
Nashville, Tennessee, 37203, United States
Tennessee Oncology Nashville
Nashville, Tennessee, 37203, United States
Tennessee Oncology SCCBC
Nashville, Tennessee, 37203, United States
Tennessee Oncology St. Thomas West
Nashville, Tennessee, 37205, United States
Tennessee Oncology Skyline
Nashville, Tennessee, 37207, United States
Tennessee Oncology Southern Hills
Nashville, Tennessee, 37211, United States
Tennessee Oncology Shelbyville
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology Stonecrest
Smyrna, Tennessee, 37167, United States
Texas Oncology - West Texas
Amarillo, Texas, 79106, United States
Texas Oncology-Bedford
Bedford, Texas, 76022, United States
TXO - Methodist Dallas Cancer Center
Dallas, Texas, 75203, United States
Texas Oncology - Dallas Forest Ln
Dallas, Texas, 75230, United States
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas, 75231, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Fort Worth
Fort Worth, Texas, 76104, United States
Texas Oncology-Southwest Fort Worth
Fort Worth, Texas, 76132, United States
Texas Oncology - Grapevine
Grapevine, Texas, 76051, United States
Texas Oncology Cancer Care and Research Center - Harlingen
Harlingen, Texas, 78550, United States
Texas Oncology - Longview Cancer Center
Longview, Texas, 75601, United States
Texas Oncology - McAllen
McAllen, Texas, 78503, United States
Texas Oncology - Mesquite
Mesquite, Texas, 75150, United States
Texas Oncology-New Braunfels
New Braunfels, Texas, 78130, United States
Texas Oncology - Plano East
Plano, Texas, 75075, United States
Texas Oncology - Plano West
Plano, Texas, 75093, United States
Texas Oncology - Rockwall
Rockwall, Texas, 75032, United States
Texas Oncology-San Antonio Downtown
San Antonio, Texas, 78212, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, 78217, United States
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, 78229, United States
Texas Oncology-San Antonio Stone Oak
San Antonio, Texas, 78258, United States
Texas Oncology - Sherman
Sherman, Texas, 75090, United States
Texas Oncology-The Woodlands
The Woodlands, Texas, 77380, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology - Weslaco
Weslaco, Texas, 78503, United States
Texas Oncology - West Texas
Wichita Falls, Texas, 76310, United States
Virginia Cancer Specialists, PC
Alexandria, Virginia, 22304, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, 22205, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, 20155, United States
Virginia Cancer Specialists, PC
Leesburg, Virginia, 20176, United States
Virginia Cancer Specialists, PC
Woodbridge, Virginia, 22191, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
Northwest Cancer Specialists, P.C. dba Compass Oncology
Vancouver, Washington, 98684, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
UHN Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Related Publications (8)
Mahal BA, Margolis M, Hubbell E, Chen C, Venstrom JM, Abran J, Kartlitz JJ, Wyatt AW, Klein EA. A Targeted Methylation-Based Multicancer Early Detection Blood Test Preferentially Detects High-Grade Prostate Cancer While Minimizing Overdiagnosis of Indolent Disease. JCO Precis Oncol. 2024 Aug;8:e2400269. doi: 10.1200/PO.24.00269.
PMID: 39208374DERIVEDBryce AH, Thiel DD, Seiden MV, Richards D, Luan Y, Coignet M, Zhang Q, Zhang N, Hubbell E, Kurtzman KN, Klein EA. Performance of a Cell-Free DNA-Based Multi-cancer Detection Test in Individuals Presenting With Symptoms Suspicious for Cancers. JCO Precis Oncol. 2023 Jul;7:e2200679. doi: 10.1200/PO.22.00679.
PMID: 37467458DERIVEDTang WHW, Yimer H, Tummala M, Shao S, Chung G, Clement J, Chu BC, Hubbell E, Kurtzman KN, Swanton C, Roberts LR. Performance of a targeted methylation-based multi-cancer early detection test by race and ethnicity. Prev Med. 2023 Feb;167:107384. doi: 10.1016/j.ypmed.2022.107384. Epub 2022 Dec 7.
PMID: 36495927DERIVEDShao SH, Allen B, Clement J, Chung G, Gao J, Hubbell E, Liu MC, Swanton C, Tang WHW, Yimer H, Tummala M. Multi-cancer early detection test sensitivity for cancers with and without current population-level screening options. Tumori. 2023 Jun;109(3):335-341. doi: 10.1177/03008916221133136. Epub 2022 Oct 31.
PMID: 36316952DERIVEDBredno J, Lipson J, Venn O, Aravanis AM, Jamshidi A. Clinical correlates of circulating cell-free DNA tumor fraction. PLoS One. 2021 Aug 25;16(8):e0256436. doi: 10.1371/journal.pone.0256436. eCollection 2021.
PMID: 34432811DERIVEDKlein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.
PMID: 34176681DERIVEDLarson MH, Pan W, Kim HJ, Mauntz RE, Stuart SM, Pimentel M, Zhou Y, Knudsgaard P, Demas V, Aravanis AM, Jamshidi A. A comprehensive characterization of the cell-free transcriptome reveals tissue- and subtype-specific biomarkers for cancer detection. Nat Commun. 2021 Apr 21;12(1):2357. doi: 10.1038/s41467-021-22444-1.
PMID: 33883548DERIVEDLiu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.
PMID: 33506766DERIVED
Biospecimen
Plasma, white blood cells, formalin fixed, paraffin embedded (FFPE) tumor tissue
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Eric Fung, MD, PhD
GRAIL, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2016
First Posted
September 7, 2016
Study Start
August 4, 2016
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
September 13, 2023
Record last verified: 2023-09