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The Circulating Cell-free Genome Atlas Study (CCGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02889978
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
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 donors with a new diagnosis of cancer (blood and tumor tissue) and from donors 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
Neoplasms 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.

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Circulating Cell-free Genome Atlas Study
Study Start Date : August 2016
Actual Primary Completion Date : February 11, 2019
Estimated Study Completion Date : March 2024

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.



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. [ Time Frame: 30 months ]
  2. To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. [ Time Frame: 30 months ]
  3. 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 ]

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. [ Time Frame: 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. [ Time Frame: Year 1, 2, 3, 4, 5 ]

Biospecimen Retention:   Samples With DNA
Plasma, white blood cells, formalin fixed, paraffin embedded (FFPE) tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889978


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Locations
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United States, Alabama
Southern Cancer Center, PC - Daphne
Daphne, Alabama, United States, 36526
Southern Cancer Center, P.C. - Mobile Infimary
Mobile, Alabama, United States, 36608
Southern Cancer Center, PC - Mobile Airport
Mobile, Alabama, United States, 36608
Southern Cancer Center, PC - Springhill Medical Center
Mobile, Alabama, United States, 36608
United States, Arizona
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Mercy Fort Smith
Fort Smith, Arkansas, United States, 72903
United States, California
Sansum Clinic - 540
Santa Barbara, California, United States, 93105
Sansum Clinic- 317
Santa Barbara, California, United States, 93105
Sansum Clinic - Viborg
Solvang, California, United States, 93463
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Center
Boulder, Colorado, United States, 80303
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers
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 Center
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers
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
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Center
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers
Thornton, Colorado, United States, 80260
United States, Connecticut
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, Connecticut, United States, 06102
Hartford New Britain
New Britain, Connecticut, United States, 06052
United States, Florida
UMHC Lennar Foundation - Coral Gables
Coral Gables, Florida, United States, 33146
UMHC Sylvester- Coral Springs
Coral Springs, Florida, United States, 33065
University of Miami Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
University of Miami Sylvester at Hollywood
Hollywood, Florida, United States, 33021
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
University of Miami Sylvester at Kendall
Kendall, Florida, United States, 33176
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Florida Cancer Affiliates - Ocala
Ocala, Florida, United States, 34471
Woodlands Medical Specialists, PA
Pensacola, Florida, United States, 32503
University of Miami Sylvester at Plantation
Plantation, Florida, United States, 33324
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Baptist Health Louisville
Louisville, Kentucky, United States, 40207
Baptist Health Paducah
Paducah, Kentucky, United States, 42003
United States, Maryland
Maryland Oncology Hematology, P.A.
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, 20902
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States, 20904
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Lahey Hospital & Medical Center - Peabody
Peabody, Massachusetts, United States, 01960
United States, Minnesota
Minnesota Oncology Hematology, P.A. - Main
Coon Rapids, Minnesota, United States, 55433
Minnesota Oncology Hematology, P.A. - Edina
Edina, Minnesota, United States, 55435
Minnesota Oncology Hematology, P.A. - Woodbury
Minneapolis, Minnesota, United States, 55404
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 32224
Minnesota Oncology Hematology, P.A. - Coon Rapids
Woodbury, Minnesota, United States, 55125
United States, Missouri
Mercy Joplin
Joplin, Missouri, United States, 64804
Mercy Research - Springfield
Springfield, Missouri, United States, 65804
United States, New Jersey
Memorial Sloan Kettering, NY - Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
Broome Oncology, LLC
Binghamton, New York, United States, 13905
New York Oncology Hematology, P.C.
Clifton Park, New York, United States, 12065
Broome Oncology, LLC
Johnson City, New York, United States, 13790
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Memorial Sloan Kettering - Basking Ridge
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
New York, New York, United States, 10065
Memorial Sloan Kettering
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care, Inc. - Reading Road
Cincinnati, Ohio, United States, 45202
Oncology Hematology Care, Inc. - Fairfield
Cincinnati, Ohio, United States, 45211
Christ Hospital Health Network - The Lindner Center Cancer Research Division
Cincinnati, Ohio, United States, 45219
Oncology Hematology Care, Inc. - Mercy Health
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care, Inc. - E. Galbraith
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care, Inc. - Malsbary
Cincinnati, Ohio, United States, 45242
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Oncology Hematology Care, Inc. - Five Mile Road
Fairfield, Ohio, United States, 45014
United States, Oregon
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, United States, 97201
Northwest Cancer Specialists, P.C. dba Compass Oncology
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
United States, Pennsylvania
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18101
Cancer Center at Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
United States, South Carolina
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Greenville Health System
Seneca, South Carolina, United States, 29672
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Oncology Medical Park II
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology Memorial Plaza
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology Cleveland Clinic
Cleveland, Tennessee, United States, 37311
Tennessee Oncology CMC
Crossville, Tennessee, United States, 38555
Tennessee Oncology Dickson
Dickson, Tennessee, United States, 37055
Tennessee Oncology Franklin
Franklin, Tennessee, United States, 37067
Tennessee Oncology Gallatin
Gallatin, Tennessee, United States, 37066
Tennessee Oncology Summit
Hermitage, Tennessee, United States, 37076
Tennessee Oncology Lebanon
Lebanon, Tennessee, United States, 37090
Tennessee Oncology Murfreesboro
Murfreesboro, Tennessee, United States, 37129
Tennessee Oncology Midtown
Nashville, Tennessee, United States, 37203
Tennessee Oncology Nashville
Nashville, Tennessee, United States, 37203
Tennessee Oncology SCCBC
Nashville, Tennessee, United States, 37203
Tennessee Oncology St. Thomas West
Nashville, Tennessee, United States, 37205
Tennessee Oncology Skyline
Nashville, Tennessee, United States, 37207
Tennessee Oncology Southern Hills
Nashville, Tennessee, United States, 37211
Tennessee Oncology Shelbyville
Shelbyville, Tennessee, United States, 37160
Tennessee Oncology Stonecrest
Smyrna, Tennessee, United States, 37167
United States, Texas
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, United States, 79106
Texas Oncology-Bedford
Bedford, Texas, United States, 76022
TXO - Methodist Dallas Cancer Center
Dallas, Texas, United States, 75203
Texas Oncology - Dallas Forest Ln
Dallas, Texas, United States, 75230
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas, United States, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology-Southwest Fort Worth
Fort Worth, Texas, United States, 76132
Texas Oncology - Grapevine
Grapevine, Texas, United States, 76051
Texas Oncology Cancer Care and Research Center - Harlingen
Harlingen, Texas, United States, 78550
Texas Oncology - Longview Cancer Center
Longview, Texas, United States, 75601
Texas Oncology - McAllen
McAllen, Texas, United States, 78503
Texas Oncology - Mesquite
Mesquite, Texas, United States, 75150
Texas Oncology-New Braunfels
New Braunfels, Texas, United States, 78130
Texas Oncology - Plano East
Plano, Texas, United States, 75075
Texas Oncology - Plano West
Plano, Texas, United States, 75093
Texas Oncology - Rockwall
Rockwall, Texas, United States, 75032
Texas Oncology-San Antonio Downtown
San Antonio, Texas, United States, 78212
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States, 78217
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, United States, 78229
Texas Oncology-San Antonio Stone Oak
San Antonio, Texas, United States, 78258
Texas Oncology - Sherman
Sherman, Texas, United States, 75090
Texas Oncology-The Woodlands
The Woodlands, Texas, United States, 77380
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Texas Oncology - Weslaco
Weslaco, Texas, United States, 78503
Texas Oncology - Wichita Falls
Wichita Falls, Texas, United States, 76310
United States, Virginia
Virginia Cancer Specialists, PC
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
United States, Washington
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Northwest Cancer Specialists, P.C. dba Compass Oncology
Vancouver, Washington, United States, 98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Canada, Ontario
UHN Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
GRAIL, Inc.
Investigators
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Study Director: Kate Kurtzman, MD GRAIL, Inc.

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Responsible Party: GRAIL, Inc.
ClinicalTrials.gov Identifier: NCT02889978     History of Changes
Other Study ID Numbers: GRAIL-001
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by GRAIL, Inc.:
Cancer Screening
High-Throughput Nucleotide Sequencing
Deep Sequencing
Circulating cell-free tumor DNA