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NCT02889978 Clinical Trial

The Circulating Cell-free Genome Atlas Study

Cancer Clinical Trial

— CCGA  

Official title:
The Circulating Cell-free Genome Atlas Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02889978
Other study ID # GRAIL-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 4, 2016
Est. completion date March 2024

Study information
Verified date September 2023
Source GRAIL, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15254
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada UHN Princess Margaret Cancer Centre Toronto Ontario
United States New York Oncology Hematology, P.C. Albany New York
United States New York Oncology Hematology, P.C. Albany New York
United States Virginia Cancer Specialists, PC Alexandria Virginia
United States Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States Texas Oncology - West Texas Amarillo Texas
United States Virginia Cancer Specialists, PC Arlington Virginia
United States Illinois Cancer Specialists Arlington Heights Illinois
United States Rocky Mountain Cancer Centers Aurora Colorado
United States Memorial Sloan Kettering - Basking Ridge Basking Ridge New Jersey
United States Texas Oncology-Bedford Bedford Texas
United States Maryland Oncology Hematology, P.A. Bethesda Maryland
United States Cancer Center at Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Broome Oncology, LLC Binghamton New York
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Rocky Mountain Cancer Center Boulder Colorado
United States Maryland Oncology Hematology, P.A. Brandywine Maryland
United States Lahey Hospital & Medical Center Burlington Massachusetts
United States Rocky Mountain Cancer Centers Centennial Colorado
United States Tennessee Oncology Medical Park II Chattanooga Tennessee
United States Tennessee Oncology Memorial Plaza Chattanooga Tennessee
United States Christ Hospital Health Network - The Lindner Center Cancer Research Division Cincinnati Ohio
United States Oncology Hematology Care, Inc. - E. Galbraith Cincinnati Ohio
United States Oncology Hematology Care, Inc. - Fairfield Cincinnati Ohio
United States Oncology Hematology Care, Inc. - Malsbary Cincinnati Ohio
United States Oncology Hematology Care, Inc. - Mercy Health Cincinnati Ohio
United States Oncology Hematology Care, Inc. - Reading Road Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Tennessee Oncology Cleveland Clinic Cleveland Tennessee
United States New York Oncology Hematology, P.C. Clifton Park New York
United States Maryland Oncology Hematology, P.A. Clinton Maryland
United States Rocky Mountain Cancer Center Colorado Springs Colorado
United States Maryland Oncology Hematology, P.A. Columbia Maryland
United States Minnesota Oncology Hematology, P.A. - Main Coon Rapids Minnesota
United States UMHC Lennar Foundation - Coral Gables Coral Gables Florida
United States UMHC Sylvester- Coral Springs Coral Springs Florida
United States Tennessee Oncology CMC Crossville Tennessee
United States Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Texas Oncology - Dallas Forest Ln Dallas Texas
United States Texas Oncology - Presbyterian Cancer Center Dallas Dallas Texas
United States TXO - Methodist Dallas Cancer Center Dallas Texas
United States Southern Cancer Center, PC - Daphne Daphne Alabama
United States University of Miami Sylvester at Deerfield Beach Deerfield Beach Florida
United States Rocky Mountain Cancer Centers Denver Colorado
United States Rocky Mountain Cancer Centers Denver Colorado
United States Tennessee Oncology Dickson Dickson Tennessee
United States Minnesota Oncology Hematology, P.A. - Edina Edina Minnesota
United States Rocky Mountain Cancer Centers Englewood Colorado
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Oncology Hematology Care, Inc. - Five Mile Road Fairfield Ohio
United States Mercy Fort Smith Fort Smith Arkansas
United States Texas Oncology-Fort Worth Fort Worth Texas
United States Texas Oncology-Southwest Fort Worth Fort Worth Texas
United States Tennessee Oncology Franklin Franklin Tennessee
United States Virginia Cancer Specialists, PC Gainesville Virginia
United States Tennessee Oncology Gallatin Gallatin Tennessee
United States Texas Oncology - Grapevine Grapevine Texas
United States Bon Secours Saint Francis Cancer Center Greenville South Carolina
United States Texas Oncology Cancer Care and Research Center - Harlingen Harlingen Texas
United States Hartford HealthCare Cancer Institute at Hartford Hospital Hartford Connecticut
United States Tennessee Oncology Summit Hermitage Tennessee
United States University of Miami Sylvester at Hollywood Hollywood Florida
United States Mayo Clinic - Florida Jacksonville Florida
United States Broome Oncology, LLC Johnson City New York
United States Mercy Joplin Joplin Missouri
United States University of Miami Sylvester at Kendall Kendall Florida
United States Rocky Mountain Cancer Center Lakewood Colorado
United States Tennessee Oncology Lebanon Lebanon Tennessee
United States Virginia Cancer Specialists, PC Leesburg Virginia
United States Baptist Health Lexington Lexington Kentucky
United States Rocky Mountain Cancer Centers Littleton Colorado
United States Rocky Mountain Cancer Centers Lone Tree Colorado
United States Rocky Mountain Cancer Centers Longmont Colorado
United States Texas Oncology - Longview Cancer Center Longview Texas
United States Baptist Health Louisville Louisville Kentucky
United States Texas Oncology - McAllen McAllen Texas
United States Texas Oncology - Mesquite Mesquite Texas
United States University of Miami Sylvester Comprehensive Cancer Center Miami Florida
United States Memorial Sloan Kettering, NY - Monmouth Middletown New Jersey
United States Minnesota Oncology Hematology, P.A. - Woodbury Minneapolis Minnesota
United States Southern Cancer Center, P.C. - Mobile Infirmary Mobile Alabama
United States Southern Cancer Center, PC - Mobile Airport Mobile Alabama
United States Southern Cancer Center, PC - Springhill Medical Center Mobile Alabama
United States Tennessee Oncology Murfreesboro Murfreesboro Tennessee
United States Tennessee Oncology Midtown Nashville Tennessee
United States Tennessee Oncology Nashville Nashville Tennessee
United States Tennessee Oncology SCCBC Nashville Tennessee
United States Tennessee Oncology Skyline Nashville Tennessee
United States Tennessee Oncology Southern Hills Nashville Tennessee
United States Tennessee Oncology St. Thomas West Nashville Tennessee
United States Texas Oncology-New Braunfels New Braunfels Texas
United States Hartford New Britain New Britain Connecticut
United States Icahn School of Medicine at Mount Sinai New York New York
United States Memorial Sloan Kettering New York New York
United States Memorial Sloan Kettering - Rockville Center New York New York
United States Memorial Sloan Kettering, NY - Commack New York New York
United States Memorial Sloan Kettering, NY - West Harrison New York New York
United States Illinois Cancer Specialists Niles Illinois
United States Florida Cancer Affiliates - Ocala Ocala Florida
United States Baptist Health Paducah Paducah Kentucky
United States Lahey Hospital & Medical Center - Peabody Peabody Massachusetts
United States Woodlands Medical Specialists, PA Pensacola Florida
United States Mayo Clinic - Arizona Phoenix Arizona
United States Texas Oncology - Plano East Plano Texas
United States Texas Oncology - Plano West Plano Texas
United States University of Miami Sylvester at Plantation Plantation Florida
United States Northwest Cancer Specialists, P.C. dba Compass Oncology Portland Oregon
United States Northwest Cancer Specialists, P.C. dba Compass Oncology Portland Oregon
United States Northwest Cancer Specialists, P.C. dba Compass Oncology Portland Oregon
United States Oregon Health & Science University Knight Cancer Institute Portland Oregon
United States Rocky Mountain Cancer Center Pueblo Colorado
United States Mayo Clinic - Rochester Rochester Minnesota
United States Maryland Oncology Hematology, P.A. Rockville Maryland
United States Texas Oncology - Rockwall Rockwall Texas
United States Texas Oncology - San Antonio Northeast San Antonio Texas
United States Texas Oncology-San Antonio Downtown San Antonio Texas
United States Texas Oncology-San Antonio Medical Center San Antonio Texas
United States Texas Oncology-San Antonio Stone Oak San Antonio Texas
United States Sansum Clinic - 540 Santa Barbara California
United States Sansum Clinic- 317 Santa Barbara California
United States Benaroya Research Institute at Virginia Mason Seattle Washington
United States Prisma Health - Upstate Seneca South Carolina
United States Tennessee Oncology Shelbyville Shelbyville Tennessee
United States Texas Oncology - Sherman Sherman Texas
United States Maryland Oncology Hematology, P.A. Silver Spring Maryland
United States Avera Research Institute Sioux Falls South Dakota
United States Tennessee Oncology Stonecrest Smyrna Tennessee
United States Sansum Clinic - Viborg Solvang California
United States Spartanburg Regional Healthcare System Spartanburg South Carolina
United States Mercy Research - Springfield Springfield Missouri
United States Texas Oncology-The Woodlands The Woodlands Texas
United States Rocky Mountain Cancer Centers Thornton Colorado
United States Northwest Cancer Specialists, P.C. dba Compass Oncology Tualatin Oregon
United States Texas Oncology - Tyler Tyler Texas
United States Northwest Cancer Specialists, P.C. dba Compass Oncology Vancouver Washington
United States Texas Oncology - Weslaco Weslaco Texas
United States Texas Oncology - West Texas Wichita Falls Texas
United States Virginia Cancer Specialists, PC Woodbridge Virginia
United States Minnesota Oncology Hematology, P.A. - Coon Rapids Woodbury Minnesota
United States Yakima Valley Memorial Hospital/North Star Lodge Yakima Washington

Sponsors (1)
Lead Sponsor Collaborator
GRAIL, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. 30 months
Primary To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject. 30 months
Secondary 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
Secondary 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
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