The Circulating Cell-free Genome Atlas Study (CCGA)

September 11, 2023 updated by: GRAIL, LLC
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

15254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • UHN Princess Margaret Cancer Centre
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, PC - Daphne
      • Mobile, Alabama, United States, 36607
        • Southern Cancer Center, P.C. - Mobile Infirmary
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC - Mobile Airport
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC - Springhill Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Arizona
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Fort Smith
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic - 540
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic- 317
      • Solvang, California, United States, 93463
        • Sansum Clinic - Viborg
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Center
      • Centennial, Colorado, United States, 80112
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Cancer Centers
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Center
      • Littleton, Colorado, United States, 80120-4413
        • Rocky Mountain Cancer Centers
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers
      • Pueblo, Colorado, United States, 81008
        • Rocky Mountain Cancer Center
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Healthcare Cancer Institute at Hartford Hospital
      • New Britain, Connecticut, United States, 06052
        • Hartford New Britain
    • Florida
      • Coral Gables, Florida, United States, 33146
        • UMHC Lennar Foundation - Coral Gables
      • Coral Springs, Florida, United States, 33065
        • UMHC Sylvester- Coral Springs
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami Sylvester at Deerfield Beach
      • Hollywood, Florida, United States, 33021
        • University of Miami Sylvester at Hollywood
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Florida
      • Kendall, Florida, United States, 33176
        • University of Miami Sylvester at Kendall
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Ocala, Florida, United States, 34471
        • Florida Cancer Affiliates - Ocala
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, PA
      • Plantation, Florida, United States, 33324
        • University of Miami Sylvester at Plantation
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
      • Paducah, Kentucky, United States, 42003
        • Baptist Health Paducah
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Maryland Oncology Hematology, P.A.
      • Brandywine, Maryland, United States, 20613
        • Maryland Oncology Hematology, P.A.
      • Clinton, Maryland, United States, 20735
        • Maryland Oncology Hematology, P.A.
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, P.A.
      • Silver Spring, Maryland, United States, 20904
        • Maryland Oncology Hematology, P.A.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
      • Peabody, Massachusetts, United States, 01960
        • Lahey Hospital & Medical Center - Peabody
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Minnesota Oncology Hematology, P.A. - Main
      • Edina, Minnesota, United States, 55435
        • Minnesota Oncology Hematology, P.A. - Edina
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A. - Woodbury
      • Rochester, Minnesota, United States, 32224
        • Mayo Clinic - Rochester
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, P.A. - Coon Rapids
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Mercy Joplin
      • Springfield, Missouri, United States, 65804
        • Mercy Research - Springfield
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering - Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering, NY - Monmouth
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C.
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P.C.
      • Binghamton, New York, United States, 13905
        • Broome Oncology, LLC
      • Clifton Park, New York, United States, 12065
        • New York Oncology Hematology, P.C.
      • Johnson City, New York, United States, 13790
        • Broome Oncology, LLC
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering - Rockville Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering, NY - Commack
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering, NY - West Harrison
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • Oncology Hematology Care, Inc. - Reading Road
      • Cincinnati, Ohio, United States, 45211
        • Oncology Hematology Care, Inc. - Fairfield
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital Health Network - The Lindner Center Cancer Research Division
      • Cincinnati, Ohio, United States, 45230
        • Oncology Hematology Care, Inc. - Mercy Health
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care, Inc. - E. Galbraith
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc. - Malsbary
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Fairfield, Ohio, United States, 45014
        • Oncology Hematology Care, Inc. - Five Mile Road
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University Knight Cancer Institute
      • Portland, Oregon, United States, 97213-2982
        • Northwest Cancer Specialists, P.C. dba Compass Oncology
      • Portland, Oregon, United States, 97225
        • Northwest Cancer Specialists, P.C. dba Compass Oncology
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists, P.C. dba Compass Oncology
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists, P.C. dba Compass Oncology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18101
        • Lehigh Valley Hospital - Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Cancer Center at Lehigh Valley Hospital - Muhlenberg
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours Saint Francis Cancer Center
      • Seneca, South Carolina, United States, 29672
        • Prisma Health - Upstate
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Healthcare System
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology Medical Park II
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology Memorial Plaza
      • Cleveland, Tennessee, United States, 37311
        • Tennessee Oncology Cleveland Clinic
      • Crossville, Tennessee, United States, 38555
        • Tennessee Oncology CMC
      • Dickson, Tennessee, United States, 37055
        • Tennessee Oncology Dickson
      • Franklin, Tennessee, United States, 37067
        • Tennessee Oncology Franklin
      • Gallatin, Tennessee, United States, 37066
        • Tennessee Oncology Gallatin
      • Hermitage, Tennessee, United States, 37076
        • Tennessee Oncology Summit
      • Lebanon, Tennessee, United States, 37090
        • Tennessee Oncology Lebanon
      • Murfreesboro, Tennessee, United States, 37129
        • Tennessee Oncology Murfreesboro
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology Nashville
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology Midtown
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology SCCBC
      • Nashville, Tennessee, United States, 37205
        • Tennessee Oncology St. Thomas West
      • Nashville, Tennessee, United States, 37207
        • Tennessee Oncology Skyline
      • Nashville, Tennessee, United States, 37211
        • Tennessee Oncology Southern Hills
      • Shelbyville, Tennessee, United States, 37160
        • Tennessee Oncology Shelbyville
      • Smyrna, Tennessee, United States, 37167
        • Tennessee Oncology Stonecrest
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - West Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology-Bedford
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Presbyterian Cancer Center Dallas
      • Dallas, Texas, United States, 75203
        • TXO - Methodist Dallas Cancer Center
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Dallas Forest Ln
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology-Fort Worth
      • Fort Worth, Texas, United States, 76132
        • Texas Oncology-Southwest Fort Worth
      • Grapevine, Texas, United States, 76051
        • Texas Oncology - Grapevine
      • Harlingen, Texas, United States, 78550
        • Texas Oncology Cancer Care and Research Center - Harlingen
      • Longview, Texas, United States, 75601
        • Texas Oncology - Longview Cancer Center
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • Mesquite, Texas, United States, 75150
        • Texas Oncology - Mesquite
      • New Braunfels, Texas, United States, 78130
        • Texas Oncology-New Braunfels
      • Plano, Texas, United States, 75093
        • Texas Oncology - Plano West
      • Plano, Texas, United States, 75075
        • Texas Oncology - Plano East
      • Rockwall, Texas, United States, 75032
        • Texas Oncology - Rockwall
      • San Antonio, Texas, United States, 78217
        • Texas Oncology - San Antonio Northeast
      • San Antonio, Texas, United States, 78212
        • Texas Oncology-San Antonio Downtown
      • San Antonio, Texas, United States, 78258
        • Texas Oncology-San Antonio Stone Oak
      • San Antonio, Texas, United States, 78229
        • Texas Oncology-San Antonio Medical Center
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology-The Woodlands
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
      • Weslaco, Texas, United States, 78503
        • Texas Oncology - Weslaco
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology - West Texas
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Virginia Cancer Specialists, PC
      • Arlington, Virginia, United States, 22205
        • Virginia Cancer Specialists, PC
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists, PC
      • Leesburg, Virginia, United States, 20176
        • Virginia Cancer Specialists, PC
      • Woodbridge, Virginia, United States, 22191
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute at Virginia Mason
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C. dba Compass Oncology
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/North Star Lodge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria for Non-Cancer Arm Participants:

  • Age 20 years or older
  • Able to provide a written informed consent

Exclusion Criteria for Non-Cancer Arm Participants:

  • 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

Inclusion Criteria for Cancer Arm Participants:

  • 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

OR

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

Exclusion Criteria for Cancer Arm Participants:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 30 months
30 months
To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin.
Time Frame: 30 months
30 months
To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject.
Time Frame: 30 months
30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Year 1, 2, 3, 4, 5
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.
Time Frame: Year 1, 2, 3, 4, 5
Year 1, 2, 3, 4, 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GRAIL, LLC

Investigators

  • Study Director: Eric Fung, MD, PhD, GRAIL, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2016

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimated)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRAIL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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