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NeoplasmsCCGANCT02889978

The Circulating Cell-free Genome Atlas Study

An observational study of Neoplasms and Cancer, run by GRAIL, Inc. at 140 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Neoplasms, Cancer
How many people
15,254 participants
Where
140 sitesin 2 countries
Study dates
4 Aug 2016to Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Age 20 years or older
  • Able to provide a written informed consent
  • Age 20 years or older
  • Able to provide a written informed consent
  • Have either of the following:
  • 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
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • Poor health status or unfit to tolerate 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)
  • 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

Trial locations and contacts

140 sites in 2 countries.

140 sites in 2 countries

United States139 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Virginia Cancer Specialists, PC

    Alexandria, Virginia, 22304

  • Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18101

  • Texas Oncology - West Texas

    Amarillo, Texas, 79106

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22205

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Memorial Sloan Kettering - Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Texas Oncology-Bedford

    Bedford, Texas, 76022

  • Maryland Oncology Hematology, P.A.

    Bethesda, Maryland, 20817

  • Cancer Center at Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Broome Oncology, LLC

    Binghamton, New York, 13905

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Center

    Boulder, Colorado, 80303

  • Maryland Oncology Hematology, P.A.

    Brandywine, Maryland, 20613

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Rocky Mountain Cancer Centers

    Centennial, Colorado, 80112

  • Tennessee Oncology Medical Park II

    Chattanooga, Tennessee, 37404

  • Tennessee Oncology Memorial Plaza

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc. - Reading Road

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care, Inc. - Fairfield

    Cincinnati, Ohio, 45211

  • Christ Hospital Health Network - The Lindner Center Cancer Research Division

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care, Inc. - Mercy Health

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care, Inc. - E. Galbraith

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care, Inc. - Malsbary

    Cincinnati, Ohio, 45242

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Tennessee Oncology Cleveland Clinic

    Cleveland, Tennessee, 37311

  • New York Oncology Hematology, P.C.

    Clifton Park, New York, 12065

  • Maryland Oncology Hematology, P.A.

    Clinton, Maryland, 20735

  • Rocky Mountain Cancer Center

    Colorado Springs, Colorado, 80907

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Minnesota Oncology Hematology, P.A. - Main

    Coon Rapids, Minnesota, 55433

  • UMHC Lennar Foundation - Coral Gables

    Coral Gables, Florida, 33146

  • UMHC Sylvester- Coral Springs

    Coral Springs, Florida, 33065

  • Tennessee Oncology CMC

    Crossville, Tennessee, 38555

  • TXO - Methodist Dallas Cancer Center

    Dallas, Texas, 75203

  • Texas Oncology - Dallas Forest Ln

    Dallas, Texas, 75230

  • Texas Oncology - Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Southern Cancer Center, PC - Daphne

    Daphne, Alabama, 36526

  • University of Miami Sylvester at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Tennessee Oncology Dickson

    Dickson, Tennessee, 37055

  • Minnesota Oncology Hematology, P.A. - Edina

    Edina, Minnesota, 55435

  • Rocky Mountain Cancer Centers

    Englewood, Colorado, 80113

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Oncology Hematology Care, Inc. - Five Mile Road

    Fairfield, Ohio, 45014

  • Mercy Fort Smith

    Fort Smith, Arkansas, 72903

  • Texas Oncology-Fort Worth

    Fort Worth, Texas, 76104

  • Texas Oncology-Southwest Fort Worth

    Fort Worth, Texas, 76132

  • Tennessee Oncology Franklin

    Franklin, Tennessee, 37067

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Tennessee Oncology Gallatin

    Gallatin, Tennessee, 37066

  • Texas Oncology - Grapevine

    Grapevine, Texas, 76051

  • Bon Secours Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Texas Oncology Cancer Care and Research Center - Harlingen

    Harlingen, Texas, 78550

  • Hartford HealthCare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06102

  • Tennessee Oncology Summit

    Hermitage, Tennessee, 37076

  • University of Miami Sylvester at Hollywood

    Hollywood, Florida, 33021

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224

  • Broome Oncology, LLC

    Johnson City, New York, 13790

  • Mercy Joplin

    Joplin, Missouri, 64804

  • University of Miami Sylvester at Kendall

    Kendall, Florida, 33176

  • Rocky Mountain Cancer Center

    Lakewood, Colorado, 80228

  • Tennessee Oncology Lebanon

    Lebanon, Tennessee, 37090

  • Virginia Cancer Specialists, PC

    Leesburg, Virginia, 20176

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Texas Oncology - Mesquite

    Mesquite, Texas, 75150

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Memorial Sloan Kettering, NY - Monmouth

    Middletown, New Jersey, 07748

  • Minnesota Oncology Hematology, P.A. - Woodbury

    Minneapolis, Minnesota, 55404

  • Southern Cancer Center, P.C. - Mobile Infirmary

    Mobile, Alabama, 36607

  • Southern Cancer Center, PC - Mobile Airport

    Mobile, Alabama, 36608

  • Southern Cancer Center, PC - Springhill Medical Center

    Mobile, Alabama, 36608

  • Tennessee Oncology Murfreesboro

    Murfreesboro, Tennessee, 37129

  • Tennessee Oncology Midtown

    Nashville, Tennessee, 37203

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Tennessee Oncology SCCBC

    Nashville, Tennessee, 37203

  • Tennessee Oncology St. Thomas West

    Nashville, Tennessee, 37205

  • Tennessee Oncology Skyline

    Nashville, Tennessee, 37207

  • Tennessee Oncology Southern Hills

    Nashville, Tennessee, 37211

  • Texas Oncology-New Braunfels

    New Braunfels, Texas, 78130

  • Hartford New Britain

    New Britain, Connecticut, 06052

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering - Rockville Center

    New York, New York, 10065

  • Memorial Sloan Kettering, NY - Commack

    New York, New York, 10065

  • Memorial Sloan Kettering, NY - West Harrison

    New York, New York, 10065

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Florida Cancer Affiliates - Ocala

    Ocala, Florida, 34471

  • Baptist Health Paducah

    Paducah, Kentucky, 42003

  • Lahey Hospital & Medical Center - Peabody

    Peabody, Massachusetts, 01960

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • Texas Oncology - Plano East

    Plano, Texas, 75075

  • Texas Oncology - Plano West

    Plano, Texas, 75093

  • University of Miami Sylvester at Plantation

    Plantation, Florida, 33324

  • Oregon Health & Science University Knight Cancer Institute

    Portland, Oregon, 97201

  • Northwest Cancer Specialists, P.C. dba Compass Oncology

    Portland, Oregon, 97213-2982

  • Northwest Cancer Specialists, P.C. dba Compass Oncology

    Portland, Oregon, 97225

  • Northwest Cancer Specialists, P.C. dba Compass Oncology

    Portland, Oregon, 97227

  • Rocky Mountain Cancer Center

    Pueblo, Colorado, 81008

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 32224

  • Maryland Oncology Hematology, P.A.

    Rockville, Maryland, 20850

  • Texas Oncology - Rockwall

    Rockwall, Texas, 75032

  • Texas Oncology-San Antonio Downtown

    San Antonio, Texas, 78212

  • Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78217

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas, 78229

  • Texas Oncology-San Antonio Stone Oak

    San Antonio, Texas, 78258

  • Sansum Clinic - 540

    Santa Barbara, California, 93105

  • Sansum Clinic- 317

    Santa Barbara, California, 93105

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Prisma Health - Upstate

    Seneca, South Carolina, 29672

  • Tennessee Oncology Shelbyville

    Shelbyville, Tennessee, 37160

  • Texas Oncology - Sherman

    Sherman, Texas, 75090

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland, 20904

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Tennessee Oncology Stonecrest

    Smyrna, Tennessee, 37167

  • Sansum Clinic - Viborg

    Solvang, California, 93463

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina, 29303

  • Mercy Research - Springfield

    Springfield, Missouri, 65804

  • Texas Oncology-The Woodlands

    The Woodlands, Texas, 77380

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260

  • Northwest Cancer Specialists, P.C. dba Compass Oncology

    Tualatin, Oregon, 97062

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C. dba Compass Oncology

    Vancouver, Washington, 98684

  • Texas Oncology - Weslaco

    Weslaco, Texas, 78503

  • Texas Oncology - West Texas

    Wichita Falls, Texas, 76310

  • Virginia Cancer Specialists, PC

    Woodbridge, Virginia, 22191

  • Minnesota Oncology Hematology, P.A. - Coon Rapids

    Woodbury, Minnesota, 55125

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

Canada1 site

  • UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Neoplasms, Cancer
Keywords
Cancer Screening, High-Throughput Nucleotide Sequencing, Deep Sequencing, Circulating cell-free tumor DNA
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02889978
Study groupRoleWhat they receive
Cancer armParticipants with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.
Non-cancer armParticipants with no known diagnosis or past history of cancer from which a blood sample will be collected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 months

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

    Measured: 30 months

  3. To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject.

    Measured: 30 months

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: Year 1, 2, 3, 4, 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study start4 Aug 2016
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02889978
Sponsor's protocol ID
GRAIL-001
Acronym
CCGA
Status last verified
Sep 2023
First submitted
18 Aug 2016
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No

Publications

  • Swanton C, Bryce A, Cohn AL, Margolis M, Hubbell E, Sagan A, Venn O, Seiden M. Prognostic Significance of Blood-Based Multicancer Detection in Circulating Tumor DNA: Five-Year Outcomes Analysis. JCO Precis Oncol. 2026 Mar;10(3):e2500725. doi: 10.1200/PO-25-00725. Epub 2026 Mar 12.

    PubMed 41818645

  • 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.

    PubMed 39208374

  • Bryce 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.

    PubMed 37467458

  • Tang 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.

    PubMed 36495927

  • Shao 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.

    PubMed 36316952

  • Bredno 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.

    PubMed 34432811

  • Klein 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.

    PubMed 34176681

  • Larson 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.

    PubMed 33883548

  • Liu 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.

    PubMed 33506766

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Cancer, run by GRAIL, Inc. at 140 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02889978, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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