Clincosm LogoSign in Get a demo

CCGA: The Circulating Cell-free Genome Atlas Study

Sponsor
GRAIL, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02889978
Collaborator
(none)
15,254
Enrollment
140
Locations
90.9
Anticipated Duration (Months)
109
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    15254 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Circulating Cell-free Genome Atlas Study
    Actual Study Start Date :
    Aug 4, 2016
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. [30 months]

    3. 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

    1. 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]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:
    1. 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Cancer Center, PC - Daphne Daphne Alabama United States 36526
    2 Southern Cancer Center, P.C. - Mobile Infirmary Mobile Alabama United States 36607
    3 Southern Cancer Center, PC - Mobile Airport Mobile Alabama United States 36608
    4 Southern Cancer Center, PC - Springhill Medical Center Mobile Alabama United States 36608
    5 Mayo Clinic - Arizona Phoenix Arizona United States 85054
    6 Mercy Fort Smith Fort Smith Arkansas United States 72903
    7 Sansum Clinic - 540 Santa Barbara California United States 93105
    8 Sansum Clinic- 317 Santa Barbara California United States 93105
    9 Sansum Clinic - Viborg Solvang California United States 93463
    10 Rocky Mountain Cancer Centers Aurora Colorado United States 80012
    11 Rocky Mountain Cancer Center Boulder Colorado United States 80303
    12 Rocky Mountain Cancer Centers Centennial Colorado United States 80112
    13 Rocky Mountain Cancer Center Colorado Springs Colorado United States 80907
    14 Rocky Mountain Cancer Centers Denver Colorado United States 80218
    15 Rocky Mountain Cancer Centers Denver Colorado United States 80220
    16 Rocky Mountain Cancer Centers Englewood Colorado United States 80113
    17 Rocky Mountain Cancer Center Lakewood Colorado United States 80228
    18 Rocky Mountain Cancer Centers Littleton Colorado United States 80120-4413
    19 Rocky Mountain Cancer Centers Lone Tree Colorado United States 80124
    20 Rocky Mountain Cancer Centers Longmont Colorado United States 80501
    21 Rocky Mountain Cancer Center Pueblo Colorado United States 81008
    22 Rocky Mountain Cancer Centers Thornton Colorado United States 80260
    23 Hartford HealthCare Cancer Institute at Hartford Hospital Hartford Connecticut United States 06102
    24 Hartford New Britain New Britain Connecticut United States 06052
    25 UMHC Lennar Foundation - Coral Gables Coral Gables Florida United States 33146
    26 UMHC Sylvester- Coral Springs Coral Springs Florida United States 33065
    27 University of Miami Sylvester at Deerfield Beach Deerfield Beach Florida United States 33442
    28 University of Miami Sylvester at Hollywood Hollywood Florida United States 33021
    29 Mayo Clinic - Florida Jacksonville Florida United States 32224
    30 University of Miami Sylvester at Kendall Kendall Florida United States 33176
    31 University of Miami Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    32 Florida Cancer Affiliates - Ocala Ocala Florida United States 34471
    33 Woodlands Medical Specialists, PA Pensacola Florida United States 32503
    34 University of Miami Sylvester at Plantation Plantation Florida United States 33324
    35 Illinois Cancer Specialists Arlington Heights Illinois United States 60005
    36 Illinois Cancer Specialists Niles Illinois United States 60714
    37 Baptist Health Lexington Lexington Kentucky United States 40503
    38 Baptist Health Louisville Louisville Kentucky United States 40207
    39 Baptist Health Paducah Paducah Kentucky United States 42003
    40 Maryland Oncology Hematology, P.A. Bethesda Maryland United States 20817
    41 Maryland Oncology Hematology, P.A. Brandywine Maryland United States 20613
    42 Maryland Oncology Hematology, P.A. Clinton Maryland United States 20735
    43 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    44 Maryland Oncology Hematology, P.A. Rockville Maryland United States 20850
    45 Maryland Oncology Hematology, P.A. Silver Spring Maryland United States 20904
    46 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    47 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805
    48 Lahey Hospital & Medical Center - Peabody Peabody Massachusetts United States 01960
    49 Minnesota Oncology Hematology, P.A. - Main Coon Rapids Minnesota United States 55433
    50 Minnesota Oncology Hematology, P.A. - Edina Edina Minnesota United States 55435
    51 Minnesota Oncology Hematology, P.A. - Woodbury Minneapolis Minnesota United States 55404
    52 Mayo Clinic - Rochester Rochester Minnesota United States 32224
    53 Minnesota Oncology Hematology, P.A. - Coon Rapids Woodbury Minnesota United States 55125
    54 Mercy Joplin Joplin Missouri United States 64804
    55 Mercy Research - Springfield Springfield Missouri United States 65804
    56 Memorial Sloan Kettering - Basking Ridge Basking Ridge New Jersey United States 07920
    57 Memorial Sloan Kettering, NY - Monmouth Middletown New Jersey United States 07748
    58 New York Oncology Hematology, P.C. Albany New York United States 12206
    59 New York Oncology Hematology, P.C. Albany New York United States 12208
    60 Broome Oncology, LLC Binghamton New York United States 13905
    61 New York Oncology Hematology, P.C. Clifton Park New York United States 12065
    62 Broome Oncology, LLC Johnson City New York United States 13790
    63 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    64 Memorial Sloan Kettering - Rockville Center New York New York United States 10065
    65 Memorial Sloan Kettering, NY - Commack New York New York United States 10065
    66 Memorial Sloan Kettering, NY - West Harrison New York New York United States 10065
    67 Memorial Sloan Kettering New York New York United States 10065
    68 Oncology Hematology Care, Inc. - Reading Road Cincinnati Ohio United States 45202
    69 Oncology Hematology Care, Inc. - Fairfield Cincinnati Ohio United States 45211
    70 Christ Hospital Health Network - The Lindner Center Cancer Research Division Cincinnati Ohio United States 45219
    71 Oncology Hematology Care, Inc. - Mercy Health Cincinnati Ohio United States 45230
    72 Oncology Hematology Care, Inc. - E. Galbraith Cincinnati Ohio United States 45236
    73 Oncology Hematology Care, Inc. - Malsbary Cincinnati Ohio United States 45242
    74 Cleveland Clinic Cleveland Ohio United States 44195
    75 Oncology Hematology Care, Inc. - Five Mile Road Fairfield Ohio United States 45014
    76 Oregon Health & Science University Knight Cancer Institute Portland Oregon United States 97201
    77 Northwest Cancer Specialists, P.C. dba Compass Oncology Portland Oregon United States 97213-2982
    78 Northwest Cancer Specialists, P.C. dba Compass Oncology Portland Oregon United States 97225
    79 Northwest Cancer Specialists, P.C. dba Compass Oncology Portland Oregon United States 97227
    80 Northwest Cancer Specialists, P.C. dba Compass Oncology Tualatin Oregon United States 97062
    81 Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18101
    82 Cancer Center at Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    83 Bon Secours Saint Francis Cancer Center Greenville South Carolina United States 29607
    84 Prisma Health - Upstate Seneca South Carolina United States 29672
    85 Spartanburg Regional Healthcare System Spartanburg South Carolina United States 29303
    86 Avera Research Institute Sioux Falls South Dakota United States 57105
    87 Tennessee Oncology Medical Park II Chattanooga Tennessee United States 37404
    88 Tennessee Oncology Memorial Plaza Chattanooga Tennessee United States 37404
    89 Tennessee Oncology Cleveland Clinic Cleveland Tennessee United States 37311
    90 Tennessee Oncology CMC Crossville Tennessee United States 38555
    91 Tennessee Oncology Dickson Dickson Tennessee United States 37055
    92 Tennessee Oncology Franklin Franklin Tennessee United States 37067
    93 Tennessee Oncology Gallatin Gallatin Tennessee United States 37066
    94 Tennessee Oncology Summit Hermitage Tennessee United States 37076
    95 Tennessee Oncology Lebanon Lebanon Tennessee United States 37090
    96 Tennessee Oncology Murfreesboro Murfreesboro Tennessee United States 37129
    97 Tennessee Oncology Midtown Nashville Tennessee United States 37203
    98 Tennessee Oncology Nashville Nashville Tennessee United States 37203
    99 Tennessee Oncology SCCBC Nashville Tennessee United States 37203
    100 Tennessee Oncology St. Thomas West Nashville Tennessee United States 37205
    101 Tennessee Oncology Skyline Nashville Tennessee United States 37207
    102 Tennessee Oncology Southern Hills Nashville Tennessee United States 37211
    103 Tennessee Oncology Shelbyville Shelbyville Tennessee United States 37160
    104 Tennessee Oncology Stonecrest Smyrna Tennessee United States 37167
    105 Texas Oncology - West Texas Amarillo Texas United States 79106
    106 Texas Oncology-Bedford Bedford Texas United States 76022
    107 TXO - Methodist Dallas Cancer Center Dallas Texas United States 75203
    108 Texas Oncology - Dallas Forest Ln Dallas Texas United States 75230
    109 Texas Oncology - Presbyterian Cancer Center Dallas Dallas Texas United States 75231
    110 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    111 Texas Oncology-Fort Worth Fort Worth Texas United States 76104
    112 Texas Oncology-Southwest Fort Worth Fort Worth Texas United States 76132
    113 Texas Oncology - Grapevine Grapevine Texas United States 76051
    114 Texas Oncology Cancer Care and Research Center - Harlingen Harlingen Texas United States 78550
    115 Texas Oncology - Longview Cancer Center Longview Texas United States 75601
    116 Texas Oncology - McAllen McAllen Texas United States 78503
    117 Texas Oncology - Mesquite Mesquite Texas United States 75150
    118 Texas Oncology-New Braunfels New Braunfels Texas United States 78130
    119 Texas Oncology - Plano East Plano Texas United States 75075
    120 Texas Oncology - Plano West Plano Texas United States 75093
    121 Texas Oncology - Rockwall Rockwall Texas United States 75032
    122 Texas Oncology-San Antonio Downtown San Antonio Texas United States 78212
    123 Texas Oncology - San Antonio Northeast San Antonio Texas United States 78217
    124 Texas Oncology-San Antonio Medical Center San Antonio Texas United States 78229
    125 Texas Oncology-San Antonio Stone Oak San Antonio Texas United States 78258
    126 Texas Oncology - Sherman Sherman Texas United States 75090
    127 Texas Oncology-The Woodlands The Woodlands Texas United States 77380
    128 Texas Oncology - Tyler Tyler Texas United States 75702
    129 Texas Oncology - Weslaco Weslaco Texas United States 78503
    130 Texas Oncology - West Texas Wichita Falls Texas United States 76310
    131 Virginia Cancer Specialists, PC Alexandria Virginia United States 22304
    132 Virginia Cancer Specialists, PC Arlington Virginia United States 22205
    133 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    134 Virginia Cancer Specialists, PC Gainesville Virginia United States 20155
    135 Virginia Cancer Specialists, PC Leesburg Virginia United States 20176
    136 Virginia Cancer Specialists, PC Woodbridge Virginia United States 22191
    137 Benaroya Research Institute at Virginia Mason Seattle Washington United States 98101
    138 Northwest Cancer Specialists, P.C. dba Compass Oncology Vancouver Washington United States 98684
    139 Yakima Valley Memorial Hospital/North Star Lodge Yakima Washington United States 98902
    140 UHN Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • GRAIL, LLC

    Investigators

    • Study Director: Kathryn N Kurtzman, MD, GRAIL, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GRAIL, LLC
    ClinicalTrials.gov Identifier:
    NCT02889978
    Other Study ID Numbers:
    • GRAIL-001
    First Posted:
    Sep 7, 2016
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by GRAIL, LLC
    Cancer Screening
    High-Throughput Nucleotide Sequencing
    Deep Sequencing
    Circulating cell-free tumor DNA

    Study Results

    No Results Posted as of Aug 3, 2022