Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
Status: Active_not_recruiting
Location: See all (270) locations...
Study Type: Observational
SUMMARY
The ECLIPSE (Evaluation of the ctDNA LUNAR test in an Average Patient Screening Episode) study is a prospective, observational multi-site study without randomization. The primary objective of the study is to evaluate the performance characteristics of a blood-based ctDNA LUNAR-2 test to detect colorectal cancer in a screen-relevant, average risk population.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 84
Healthy Volunteers: t
View:
• Subjects aged 45-84 years at time of consent
• Intended to undergo screening colonoscopy
• Considered by a physician or healthcare provider as being of 'average risk' for CRC
• Willing to consent to blood draw pre-bowel preparation administration prior to undergoing colonoscopy within 60 days of the date of the investigational blood draw
• Willing to consent to follow-up for two years as per protocol
Locations
United States
Alabama
Pinnacle Research Group, LLC
Anniston
Lakeview Clinical Research
Guntersville
Medical Affiliated Research Center
Huntsville
Jasper Summit Research LLC
Jasper
Arkansas
Preferred Research Partners, Inc
Little Rock
Premier Gastroenterology
Little Rock
Arkansas Gastroenterology
North Little Rock
Arizona
Hope Research Institute
Chandler
Southeast Valley Gastroenterology
Chandler
Prime Medical Group, LLC
Gilbert
Hope Research Institute
Glendale
Forty-Third Medical Associates Absolute Clinical Research
Phoenix
GI Research Associates, LLC
Phoenix
Del Sol Research Management, LLC
Tucson
Novak Clinical Research
Tucson
California
Associated Gastroenterology Medical Group
Anaheim
InSite Digestive Health Care
Arcadia
Gastroenterology
Burlingame
Ventura County Gastroenterology Medical Group
Camarillo
Alliance Research Institute
Canoga Park
Hope Clinical Research
Canoga Park
Gastro SB Clinic
Chula Vista
Precision Research Institute
Chula Vista
BG Clinical Research and affiliate of The Clinical Trials Network, LLC
Encinitas
Diagnamics, Inc
Encinitas
Helping Hands Healthcare Group
Fullerton
Paragon RX Clinical, Inc.
Garden Grove
Digestive Health Research of Southern California
Huntington Beach
United Medical Doctors
Irvine
Gastro Care Institute
Lancaster
Gastroenterology Associates of Beverly Hills
Los Angeles
LA Gastroenterology Group
Los Angeles
University of Southern California
Los Angeles
Knowledge Research Center
Orange
InSite Digestive Health Care-San Gabriel
Oxnard
Desert Oasis Healthcare Medical Group
Palm Springs
Palm Tree Clinical, Inc
Palm Springs
InSite Digestive Health Care - Gastroenterology Associates
Pasadena
Northern California Research
Sacramento
Medical Associates Research Group
San Diego
Precision Research Institute
San Diego
San Diego Gastroenterology Medical Associates
San Diego
SDG Clinical Research, Inc.
San Diego
FOMAT Simoni AGI Medical
Thousand Oaks
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc
Toluca Lake
Clinical Research of California
Walnut Creek
Curebase
Walnut Creek
Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport
CMR of Greater New Haven, LLC
Hamden
Yale University
New Haven
Florida
Innovative Medical Research of South Florida, Inc.
Aventura
Reciomed Clinical Research Network, Inc.
Boynton Beach
Clinical Research of South Florida, an AMR Company
Coral Gables
Dolphin Medical Research
Doral
University of Florida College of Medicine
Gainesville
Palmetto Research, LLC
Hialeah
Research Centers of America
Hollywood
The Center for Gastrointestinal Disorders
Hollywood
Health Awareness, Inc
Jupiter
Jupiter Medical Center
Jupiter
Multi-Specialty Research Associates
Lake City
University Clinical Research-DeLand, LLC dba Accel Research Sites
Lake Mary
Florida Research Institute
Lakewood Ranch
University Clinical Research-DeLand, LLC dba Accel Research Sites
Melbourne
Crystal Biomedical Research
Miami Lakes
Ocala GI Research, LLC
Ocala
Sarkis Clinical Trials
Ocala
Gastroenterology of Greater Orlando
Orange City
Gastroenterology Institute of Orlando
Orlando
Advanced Gastroenterology Associates, LLC
Palm Harbor
Precision Clinical Research, LLC
Sunrise
Guardian Angel Research Center, LLC
Tampa
Georgia
Digestive Health Care of Georgia
Atlanta
Emory University School of Medicine
Atlanta
Metro Atlanta Gastroenterology, LLC.
Atlanta
Columbus Regional Research Institute
Columbus
Gastroenterology Consultants of Augusta
Evans
SKY Clinical Research Network Group
Lawrenceville
Infinite Clinical Trials
Riverdale
WR-Mount Vernon Clinical Research, LLC
Sandy Springs
Rolphe Adult and Pediatric Medicine
Union City
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Christie Clinic
Champaign
Curebase
Chicago
University of Chicago Medicine
Chicago
Digestive Health Services
Downers Grove
Edward Hines Jr. VA Hospital
Hines
Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research
Lake Barrington
Suburban Gastroenterology Ltd
Naperville
Comprehensive Gastrointestinal Health
Northbrook
DM Clinical Research
Oak Lawn
Rockford Gastroenterology Associates, Ltd.
Rockford
Indiana
Digestive Research Alliance of Michiana
South Bend
Kansas
Alliance for Multispecialty Research, LLC
El Dorado
West Glen Gastrointestinal Consultants, P.A.
Shawnee Mission
Alliance for Multispecialty Research-Wichita West
Wichita
Kansas Gastroenterology, LLC
Wichita
Kentucky
Tri-State Gastroenterology Associates
Crestview Hills
Robley Rex VA Medical Center
Louisville
University of Louisville Research Foundation
Louisville
Louisiana
Northlake Gastroenterology Associates
Covington
Northlake Gastroenterology Associates
Hammond
CroNola LLC
Houma
Gastroclinic
Lafayette
Clinical Trials of SWLA, LLC
Lake Charles
Delta Research Partners
Monroe
Louisiana Research Center, LLC
Shreveport
Massachusetts
Digestive Health Specialists
Chelmsford
South Suburban Gastroenterology
South Weymouth
Maryland
Gastro Center of Maryland
Columbia
Centennial Medical Group
Elkridge
Frederick Gastroenterology Associates
Frederick
Mid-Atlantic GI Research
Greenbelt
Meridian Clinical Research
Rockville
Michigan
University of Michigan
Ann Arbor
Onyx Clinical Research
Rochester Hills
Covenant HealthCare
Saginaw
Revive Research Institute, LLC
Southfield
Clinical Research Institute of Michigan, LLC
Troy
Minnesota
Curebase
Eagan
Missouri
Clinical Research Professionals, LLC
Chesterfield
Digestive Health Specialists, LLC
Saint Joseph
Saint Louis University GI & Hepatology Research Unit
Saint Louis
Sundance Clinical Research
Saint Louis
Washington University School of Medicine Gastroenterology
Saint Louis
Mississippi
Gastroenterology Associates of Mississippi
Columbus
Southern Therapy and Advanced Research
Jackson
Quinn Healthcare
Ridgeland
North Carolina
Digestive Health Partners
Asheville
Cary Gastro Associates
Cary
UNC Division of Gastroenterology and Hepatology
Chapel Hill
Carolina Digestive Health Associates, PA
Charlotte
Carolinas Research Center
Charlotte
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte
Javara Research
Charlotte
Carolina Digestive Health Associates, PA
Concord
Northeast GI Research Division
Concord
Coastal Research Institute, LLC
Fayetteville
Medication Management LLC
Greensboro
Pinehurst Medical Clinic
Pinehurst
Carolina's GI Research, LLC
Raleigh
PMG Research of Raleigh
Raleigh
Boice Willis Clinic, PA
Rocky Mount
PMG Research of Salisbury, LLC
Salisbury
Piedmont HealthCare, PA
Statesville
Trial Management Associates, LLC
Wilmington
Wilmington Health
Wilmington
PMG Research of Winston
Winston-salem
North Dakota
Lillestol Research, LLC
Fargo
Plains Clinical Research Center, LLC
Fargo
Nebraska
Skyline Medical Center, PC/CCT Research
Elkhorn
Midwest Regional Health Services, LLC/CCT Research
Omaha
New Jersey
Hassman Research Institute
Berlin
Allied Health Clinical Research Organization, LLC
Brick
Gastroenterology Associates Of New Jersey
Clifton
AIG Digestive Disease Research
Florham Park
Allied Health Clinical Research Organization, LLC
Freehold
Hackensack Digestive Disease Associates
Hackensack
Digestive Healthcare Center
Hillsborough
Allied Health Clinical Research Organization
Jackson
Gastroenterology Associates Of New Jersey
Montclair
Dr. Howard N. Guss and Dr. Gagan Beri
Ocean City
Gastroenterology Associates Of New Jersey
Ridgewood
Teaneck Gastroenterology Associates
Teaneck
Advanced Gastroenterology Group
Union
Gastroenterology Associates Of New Jersey
Wayne
North Jersey Gastroenterology
Wayne
Gastroenterology Associates Of New Jersey
Woodland Park
New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque
Nevada
Excel Clinical Research
Las Vegas
Wr-Crcn, Llc
Las Vegas
Advanced Research Institute
Reno
Gastroenterology Consultants
Reno
Gastroenterology Consultants
Reno
New York
NY Scientific
Brooklyn
Sam Moskowitz, MD
Brooklyn
Associated Gastroenterologists of Central New York, Camillus
Camillus
Associated Gastroenterology of Central New York
East Syracuse
Associated Gastroenterologists of Central New York
Fayetteville
Intercity Gastroenterology
Fresh Meadows
South Island Gastro
Lawrence
East End Gastroenterology & Hepatology
Manorville
Gastrointestinal Associates of Rockland
New City
Smart Medical Research
Richmond Hill
Syracuse Gastro Associates
Syracuse
Digestive Disease Medicine Of Central New York
Utica
GastroCare LI
Valley Stream
Gastrointestinal Specs Lng Is
Wantagh
Eric L. Tatar, MD
West Nyack
Ohio
Gastroenterology Associates of Cleveland
Beachwood
Dayton Gastroenterology
Beavercreek
Dayton Gastroenterology, Inc.
Beavercreek
Gastro Health Research
Cincinnati
University of Cincinnati
Cincinnati
ClinOhio Research Services
Columbus
Advance Clinical Research
Dayton
META Medical Research Institute
Dayton
Great Lakes Gastroenterology
Mentor
DSI Research, LLC
Springboro
University of Toledo Internal Medicine Clinic
Toledo
Avamar Gastroenterology and Center
Warren
Northshore Gastroenterology & Endoscopy Center
Westlake
Oklahoma
Digestive Disease Specialists, Inc
Oklahoma City
Options Health Research, LLC
Tulsa
Oregon
Fanno Creek Group
Portland
The Oregon Clinic - Gastroenterology East
Portland
Pennsylvania
Eastern Pennsylvania GI & Liver Specialists
Allentown
US Digestive Health at Blair
Altoona
Valley Gastroenterology Associates
Beaver Falls
Susquehanna Research Group, LLC
Camp Hill
Susquehanna Research Group
Harrisburg
Einstein Medical Center Department of Digestive Disease and Transplantation
Philadelphia
Perelman Center for Advanced Medicine
Philadelphia
Frontier Clinical Research, LLC
Uniontown
Rhode Island
GIMED Associates, Inc.
Cranston
GIMED Associates, Inc.
Narragansett
South Carolina
Digestive Disease Research Center
Greenwood
Coastal Carolina Research Center
Mount Pleasant
Southeast Medical Research/Elms Research
North Charleston
South Carolina Clinical Research LLC
Orangeburg
PPCP Division of Gastroenterology LLC
Summerville
Invocare Medical Research & Healthcare Center
West Columbia
Tennessee
Elligo Clinical Research Center
Austin
Erlanger Health Clinical Resarch
Chattanooga
WR-ClinSearch, LLC
Chattanooga
Gastro One
Germantown
Helios Clinical Research lLC
Jackson
The Jackson Clinic
Jackson
The Jackson Clinic, PA
Jackson
East Tennessee Research Institute
Johnson City
Tri-Cities Gastroenterology
Kingsport
Gastrointestinal Associates, P.C.
Knoxville
Vanderbilt University Medical Center
Nashville
Advanced Gastroenterology
Union City
Texas
Allied Digestive Disease Center
Cypress
Northside Gastroenterology Associates
Cypress
Uma Mohan MD PA
Cypress
El Paso Integrated Physicians Group, P.A.
El Paso
Biopharma Informatic
Houston
Digestive Health Associates
Houston
Diversified Medical Practices
Houston
Houston Digestive Diseases Consultants
Houston
Memorial Hermann Surgery Center
Houston
University of Texas MD Anderson Cancer Center
Houston
Protenium Clinical Research Inc.
Hurst
Biopharma Informatic
Mcallen
Gastroenterology Consultants, P.A.
Pasadena
Clinical Associates in Research Therapeutics of America
San Antonio
Gastroenterology Partners of North Houston
Shenandoah
Texas Gastroenterology Associates/A1 Clinical Network
Spring
Gastroenterology Associates of Texas, PA
Sugar Land
Texas Gastro Consultants
Tomball
Digestive Health Research of North Texas
Wichita Falls
Utah
Progressive Clinical Research
Bountiful
Advanced Research Institute
Ogden
Advanced Research Institute Granite Peaks Gastroenterology
Sandy
Virginia
Charlottesville Medical Research
Charlottesville
Gastroenterology Associates of Tidewater
Chesapeake
Verity Research
Fairfax
Blue Ridge Medical Research
Lynchburg
The Gastroenterology Group
Reston
GI Select Health Research, LLC
Richmond
Tidewater Physicians Multispecialty Group Clinical Research
Williamsburg
Washington
Washington Gastroenterology
Bellevue
Western Washington Medical Group, Inc
Everett
Velocity Clinical Research
Spokane
Wisconsin
Holy Family Memorial, Inc
Manitowoc
Medical College of Wisconsin
Milwaukee
GI Associates
Stevens Point
GI Associates
Wausau
Time Frame
Start Date: 2019-10-08
Completion Date: 2025-12-31
Participants
Target number of participants: 44467
Authors
Michael Jardula, Eric Frizzell, Neeraja Maramreddy, Kiran Jagarlamudi, Tasha Boone, Ricardo McCall, Xavier Llor, Tamara Doehner, John Lowe, Christopher Ferris, Soonbok Grace Woo, Jorge Castaneda, James Maher, Seela Ramesh, Duane Anderson, Kofi Nuako, Maninder Guram, Khaldoun Debian, James Beach, Fred Fowler, Robert Bresalier, Babatunde Adeyefa, George Vagujhelyi, Chester Maxson, Bezawit Tekola, Omer Khalid, Naveen Reddy, Gary Goldstein, Kamran Ayub, Alan Cutler, Anita Wolke, Bob Souder, Ramin Farsad, Stephen Fry, Louis Wilson, David Neumann, Vivek Trivedi, William Nixon, Ramkrishna Surendran, Angelo Coppola, Vinay Patel, Erik Kerekes, Amy Seinfeld, Valli Kodali, Arun Khazanchi, Benjamin Thomas, Ralph Alhalel, Alaa Abousaif, Jan Westerman, Ghulamullah Shahzad, Timothy Quinn, James Buxbaum, Robert Goldklang, Sukhdeep Padda, Ervin Eaker, Rehan Iftikhar, Nathaniel Winstead, Emil Annabi, Avraham Levin, John Weber, Keith Friedenberg, Vijay Jayaraman, James Walter, Erick Alayo, Ronald Surowitz, Jeffrey Lefkovitz, William Harlan, Robert Wohlman, Javier Sobrado, Nadia Cameron, Rica Santiago, Cainan Foltz, Angel Rico, Jerry Gaston, Kumaravel Perumalsamy, Brian Borg, Jeremy Anclam, Farid Naffah, Jeffrey Nathanson, Pankaj Kashyap, Hoadley Harris, Joseph Soufer, Bechara Mezher, Ernest Ribera, Samuel Mourani, Harvey Allen, Andrew Cummins, Sean Hunt, Frederick Ruthardt, Sanjib Mohanty, Jason Taylor, Leonard Weinstock, Douglas Young, Carl Wallach, Robert Strzinek, Mark McKenzie, Robert Barnett, Phillip Kiyasu, Ugochukwu Nwokoro, John Hill, Humberto Aguilar, Mouhamad Al-Sabbagh, Craig Deligdish, Harvey Tatum, Frances Jones, Michael Marsh, Glenn Littenberg, Dwight Blake, Jennifer Christie, Brian Webster, Anjali Morey, Guy Strauss, Niaz Usman, Jeffrey Rosen, Priyesh Mehta, Dana Pan, Michael Hassman, Shahid Ali, Bryson Katona, Jyothi Mann, Jawahar Taunk, Cynthia Schaeffer, Lindsey Surace, Reid Ness, Ronnie Cyzner, Louis Lambiase, Christopher Connolley, Endashaw Omer, Ben Ogunwale, Geetanjali Akerkar, John Baber, Uma Mohan, William Fitzgibbons, Robyn Haithcock, David Nemoto, Karen Simon, Scott Wofford, Shankar Thiruppathi, Maryam Sattari, Felix Tiongco, Jaime Mayoral, Ayub Hussain, Michael Rausch, Sunildat Maheshwari, Gowrappala Ramesh, Robert Barish, Neil Sengupta, Subhash Gumber, Eva Beaulieu, Justin Miller, Isaac Bassan, Daniel Pambianco, Ziad Younes, Steven Ugbarugba, Amit Gajera, William Basri, Colin Brown, Loren Brook, Gregg Coodley, Kulwinder Dua, Alexander Brun, Rudrajit Rai, Michael Lillestol, Michael Galambos, Pedram Enayati, Strick Woods, Luis Lopez
Related Therapeutic Areas
Sponsors
Leads: Guardant Health, Inc.
Collaborators: Premier Research Group plc