Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode

Status: Recruiting
Location: See all (205) 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: Accepts Healthy Volunteers
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
Recruiting
Anniston
Lakeview Clinical Research
Recruiting
Guntersville
Medical Affiliated Research Center
Recruiting
Huntsville
Jasper Summit Research LLC
Recruiting
Jasper
Arkansas
Preferred Research Partners, Inc
Recruiting
Little Rock
Premier Gastroenterology
Recruiting
Little Rock
Arkansas Gastroenterology
Recruiting
North Little Rock
Arizona
East Valley Gastroenterology & Hepatology
Recruiting
Chandler
Prime Medical Group, LLC
Recruiting
Gilbert
Arrowhead Gastroneterology Associates
Recruiting
Glendale
Forty-Third Medical Associates Absolute Clinical Research
Recruiting
Phoenix
Del Sol Research Management, LLC
Recruiting
Tucson
Del Sol Research Management, LLC
Recruiting
Tucson
Del Sol Research Management, LLC
Recruiting
Tucson
Novak Clinical Research
Recruiting
Tucson
California
InSite Digestive Health Care
Recruiting
Arcadia
Ernest F. Ribera Gastroenterology
Recruiting
Burlingame
Ventura County Gastroenterology Medical Group
Recruiting
Camarillo
Alliance Research Institute
Recruiting
Canoga Park
Hope Clinical Research
Recruiting
Canoga Park
Gastro SB Clinic
Recruiting
Chula Vista
Precision Research Institute
Recruiting
Chula Vista
Coastal Gastroenterology
Recruiting
Encinitas
Diagnamics, Inc
Recruiting
Encinitas
Helping Hands Healthcare Group
Recruiting
Fullerton
Paragon RX Clinical, Inc.
Recruiting
Garden Grove
Digestive Health Research of Southern California
Recruiting
Huntington Beach
United Medical Doctors
Recruiting
Irvine
Gastro Care Institute
Recruiting
Lancaster
Gastroenterology Associates of Beverly Hills
Recruiting
Los Angeles
University of Southern California
Recruiting
Los Angeles
Knowledge Research Center
Recruiting
Orange
FOMAT Medical Research
Recruiting
Oxnard
Desert Oasis Healthcare Medical Group
Recruiting
Palm Springs
Palm Tree Clinical, Inc
Recruiting
Palm Springs
FOMAT Medical Research
Recruiting
Pasadena
Northern California Research
Recruiting
Sacramento
Great Lakes Medical Research within San Diego
Recruiting
San Diego
Medical Associates Research Group
Recruiting
San Diego
Precision Research Institute
Recruiting
San Diego
FOMAT Simoni AGI Medical
Recruiting
Thousand Oaks
Medical Partners Toluca Lake
Recruiting
Toluca Lake
Clinical Research of California
Recruiting
Walnut Creek
Curebase
Recruiting
Walnut Creek
Connecticut
Gastroenterology Associates of Fairfield County
Recruiting
Bridgeport
CMR of Greater New Haven, LLC
Recruiting
Hamden
Yale University
Recruiting
New Haven
Florida
Innovative Medical Research of South Florida, Inc.
Recruiting
Aventura
Reciomed Clinical Research Network, Inc.
Recruiting
Boynton Beach
Alliance for Multispecialty Research
Recruiting
Coral Gables
Dolphin Medical Research
Recruiting
Doral
University of Florida College of Medicine
Recruiting
Gainesville
Palmetto Research, LLC
Recruiting
Hialeah
Research Centers of America
Recruiting
Hollywood
Health Awareness, Inc
Recruiting
Jupiter
Jupiter Medical Center
Recruiting
Jupiter
Multi-Specialty Research Associates
Recruiting
Lake City
Florida Research Institute Florida Digestive Health Specialists
Recruiting
Lakewood Ranch
OMNI Healthcare
Recruiting
Melbourne
Crystal Biomedical Research
Recruiting
Miami Lakes
Ocala GI Research, LLC
Recruiting
Ocala
Sarkis Clinical Trials
Recruiting
Ocala
Avail Clinical Research
Recruiting
Orange City
Gastroenterology Institute of Orlando
Recruiting
Orlando
Advanced Gastroenterology Associates, LLC
Recruiting
Palm Harbor
Precision Clinical Research, LLC
Recruiting
Sunrise
Guardian Angel Research Center, LLC
Recruiting
Tampa
Georgia
Digestive Health Care of Georgia
Recruiting
Atlanta
Emory University School of Medicine
Recruiting
Atlanta
Gastrointestinal Diseases Research
Recruiting
Columbus
Balanced Life Health Care Solutions SKY Clinical Research Network Group
Recruiting
Lawrenceville
Infinite Clinical Trials
Recruiting
Riverdale
Mount Vernon Clinical Research
Recruiting
Sandy Springs
Rolphe Adult and Pediatric Medicine
Recruiting
Union City
Iowa
University of Iowa Hospitals and Clinics
Recruiting
Iowa City
Illinois
Christie Clinic
Recruiting
Champaign
University of Chicago Medicine
Recruiting
Chicago
Edward Hines Jr. VA Hospital
Recruiting
Hines
Comprehensive Gastrointestinal Health
Recruiting
Northbrook
DM Clinical Research
Recruiting
Oak Lawn
Rockford Gastroenterology Associates, Ltd.
Recruiting
Rockford
Indiana
Digestive Research Alliance of Michiana
Recruiting
South Bend
Kansas
Heartland Research Associates, an AMR Company
Recruiting
El Dorado
West Glen Gastrointestinal Consultants, P.A.
Recruiting
Shawnee Mission
Professional Research Network of Kansas, LLC
Recruiting
Wichita
Kentucky
University of Louisville Research Foundation
Recruiting
Louisville
Louisiana
CroNola LLC
Recruiting
Houma
Gastroclinic
Recruiting
Lafayette
Clinical Trials of SWLA, LLC
Recruiting
Lake Charles
Delta Research Partners
Recruiting
Monroe
Louisiana Research Center, LLC
Recruiting
Shreveport
Massachusetts
Digestive Health Specialists
Recruiting
Chelmsford
Maryland
Gastro Center of Maryland
Recruiting
Columbia
Centennial Medical Group
Recruiting
Elkridge
Frederick Gastroenterology Associates
Recruiting
Frederick
Mid-Atlantic GI Research
Recruiting
Greenbelt
Meridian Clinical Research
Recruiting
Rockville
Michigan
University of Michigan
Recruiting
Ann Arbor
Onyx Clinical Research
Recruiting
Rochester Hills
Revive Research Institute, LLC
Recruiting
Southfield
CDH Research - Troy Gastroenterology
Recruiting
Troy
Missouri
Clinical Research Professionals, LLC
Recruiting
Chesterfield
Digestive Health Specialists, LLC
Recruiting
Saint Joseph
Saint Louis University GI & Hepatology Research Unit
Recruiting
Saint Louis
Sundance Clinical Research
Recruiting
Saint Louis
Mississippi
Southern Therapy and Advanced Research
Recruiting
Jackson
Quinn Healthcare
Recruiting
Ridgeland
North Carolina
Digestive Health Partners
Recruiting
Asheville
UNC Division of Gastroenterology and Hepatology
Recruiting
Chapel Hill
Carolinas Research Center
Recruiting
Charlotte
Charlotte Gastroenterology & Hepatology, PLLC
Recruiting
Charlotte
Javara Research
Recruiting
Charlotte
PMG Research
Recruiting
Charlotte
Northeast GI Research Division
Recruiting
Concord
PMG Research of Charlotte
Recruiting
Concord
Cumberland Research Associates
Recruiting
Fayetteville
Medication Management LLC
Recruiting
Greensboro
Innovo Research- Pinehurst Medical Clinic
Recruiting
Pinehurst
Carolina's GI Research, LLC
Recruiting
Raleigh
PMG Research of Raleigh
Recruiting
Raleigh
PMG Research of Rocky Mount
Recruiting
Rocky Mount
PMG Research of Salisbury, LLC
Recruiting
Salisbury
PMG Research of Piedmont Healthcare
Recruiting
Statesville
Trial Management Associates, LLC
Recruiting
Wilmington
Wilmington Health
Recruiting
Wilmington
PMG Research of Winston
Recruiting
Winston-salem
North Dakota
Lillestol Research, LLC
Recruiting
Fargo
Plains Clinical Research Center, LLC
Recruiting
Fargo
Nebraska
Cognitive Clinical Trials
Recruiting
Elkhorn
West Omaha Family Physicians/CCT Research
Recruiting
Omaha
New Jersey
Hassman Research Institute
Recruiting
Berlin
AIG Digestive Disease Research
Recruiting
Florham Park
Middlesex Monmouth Gastroenterology
Recruiting
Freehold
Allied Health Clinical Research Organization
Recruiting
Jackson
Nevada
Excel Clinical Research
Recruiting
Las Vegas
Wake Research - Clinical Research Center of Nevada
Recruiting
Las Vegas
Advanced Research Institute
Recruiting
Reno
New York
NY Scientific
Recruiting
Brooklyn
Intercity Gastroenterology
Recruiting
Fresh Meadows
Smart Medical Research
Recruiting
Richmond Hill
Digestive Disease Medicine Of Central New York
Recruiting
Utica
Ohio
Gastroenterology Associates of Cleveland
Recruiting
Beachwood
Dayton Gastroenterology
Recruiting
Beavercreek
Consultants for Clinical Research
Recruiting
Cincinnati
University of Cincinnati
Recruiting
Cincinnati
ClinOhio Research Services
Recruiting
Columbus
Advance Clinical Research
Recruiting
Dayton
META Medical Research Institute
Recruiting
Dayton
Great Lakes Gastroenterology
Recruiting
Mentor
DSI Research, LLC
Recruiting
Springboro
University of Toledo Internal Medicine Clinic
Recruiting
Toledo
Avamar Gastroenterology and Center
Recruiting
Warren
Northshore Gastroenterology & Endoscopy Center
Recruiting
Westlake
Oklahoma
DDSI Clinical Trials
Recruiting
Oklahoma City
Options Health Research, LLC
Recruiting
Tulsa
Oregon
Fanno Creek Group
Recruiting
Portland
The Oregon Clinic - Gastroenterology East
Recruiting
Portland
Pennsylvania
Susquehanna Research Group
Recruiting
Harrisburg
Einstein Medical Center Department of Digestive Disease and Transplantation
Recruiting
Philadelphia
University of Pennsylvania
Recruiting
Philadelphia
Frontier Clinical Research, LLC
Recruiting
Uniontown
South Carolina
Digestive Disease Research Center
Recruiting
Greenwood
Coastal Carolina Research Center
Recruiting
Mount Pleasant
South Carolina Clinical Research LLC
Recruiting
Orangeburg
Invocare Medical Research & Healthcare Center
Recruiting
West Columbia
Tennessee
ClinSearch Research Specialists
Recruiting
Chattanooga
Erlanger Health Clinical Resarch
Recruiting
Chattanooga
Gastro One
Recruiting
Germantown
Clinical Research Solutions
Recruiting
Jackson
The Jackson Clinic
Recruiting
Jackson
Tri-Cities Gastroenterology
Recruiting
Kingsport
Vanderbilt University Medical Center
Recruiting
Nashville
Advanced Gastroenterology
Recruiting
Union City
Texas
Allied Digestive Disease Center
Recruiting
Cypress
Horizon Clinical Research Group, LLC
Recruiting
Cypress
Northside Gastroenterology Associates
Recruiting
Cypress
El Paso Integrated Physicians Group, P.A.
Recruiting
El Paso
Biopharma Informatic
Recruiting
Houston
Biopharma Informatic, LLC
Recruiting
Houston
Biopharma Informatic, LLC
Recruiting
Houston
Clinical Research Solutions, LLC. within Digestive Health Associates
Recruiting
Houston
Hope Digestive and Liver Disease Clinic of Houston
Recruiting
Houston
Houston Digestive Diseases Consultants
Recruiting
Houston
MD Anderson Cancer Center Gastroenterology
Recruiting
Houston
Protenium Clinical Research Inc.
Recruiting
Hurst
Biopharma Informatic
Recruiting
Mcallen
Gastroenterology Consultants, P.A.
Recruiting
Pasadena
Clinical Associates in Research Therapeutics of America
Recruiting
San Antonio
Texas Gastroenterology Associates/A1 Clinical Network
Recruiting
Spring
Digestive Health Research of North Texas
Recruiting
Wichita Falls
Utah
Progressive Clinical Research
Recruiting
Bountiful
Advanced Research Institute
Recruiting
Ogden
Advanced Research Institute Granite Peaks Gastroenterology
Recruiting
Sandy
Virginia
Charlottesville Medical Research
Recruiting
Charlottesville
Gastroenterology Associates of Tidewater
Recruiting
Chesapeake
Verity Research
Recruiting
Fairfax
Blue Ridge Medical Research
Recruiting
Lynchburg
The Gastroenterology Group
Recruiting
Reston
GI Select Health Research, LLC
Recruiting
Richmond
MG Clinical Research Williamsburg
Recruiting
Williamsburg
Washington
Washington Gastroenterology
Recruiting
Bellevue
Western Washington Medical Group, Inc
Recruiting
Everett
Velocity Clinical Research
Recruiting
Spokane
Wisconsin
Holy Family Memorial, Inc
Recruiting
Manitowoc
Medical College of Wisconsin
Recruiting
Milwaukee
Contact Information
Primary
Erika Vento-Gaudens, MBA
egaudens@guardanthealth.com
707-342-8691
Backup
Guilnor Afalla Placido
ECLIPSE@guardanthealth.com
650-503-1814
Time Frame
Start Date: October 8, 2019
Estimated Completion Date: January 1, 2024
Participants
Target number of participants: 20000
Authors
Eric Frizzell, Neeraja Maramreddy, Kiran Jagarlamudi, Gregg Coodley, Tasha Boone, Ricardo McCall, Xavier Llor, Tamara Doehner, John Lowe, Soonbok Grace Woo, Ziad Younes, Jorge Castaneda, James Maher, Seela Ramesh, Duane Anderson, Daniel Pambianco, Kofi Nuako, Maninder Guram, Khaldoun Debian, James Beach, Fred Fowler, Robert Bresalier, Babatunde Adeyefa, George Vagujhelyi, Michael Lillestol, Chester Maxson, Pedram Enayati, Michael Jardula, Bezawit Tekola, Ghulam Khan, Omer Khalid, Gary Goldstein, Alan Cutler, Colin Brown, Anita Wolke, Bob Souder, Ramin Farsad, Stephen Fry, Kathryn Lang, Louis Wilson, Vivek Trivedi, Hoa Nguyen, William Nixon, John Rubino, Angelo Coppola, Erik Kerekes, Amy Seinfeld, Valli Kodali, Arun Khazanchi, Ralph Alhalel, Robert Barnett, Seth Crockett, Alaa Abousaif, Jacob Breaux, Michael Galambos, Jan Westerman, Ghulamullah Shahzad, Kulwinder Dua, Timothy Quinn, James Buxbaum, Robert Goldklang, Sukhdeep Padda, Ervin Eaker, Rehan Iftikhar, Nathaniel Winstead, Emil Annabi, Rudrajit Rai, Avraham Levin, John Weber, Keith Friedenberg, Vijay Jayaraman, James Walter, Andrew Bartlett, Justin Miller, Erick Alayo, Ronald Surowitz, Jeffrey Lefkovitz, William Harlan, Robert Wohlman, Javier Sobrado, Nadia Cameron, Rica Santiago, Ravi Patel, Cainan Foltz, Angel Rico, Jerry Gaston, Kumaravel Perumalsamy, Brian Borg, Jeremy Anclam, Farid Naffah, Jeffrey Nathanson, Pankaj Kashyap, Steven Ugbarugba, Loren Brook, Hoadley Harris, Joseph Soufer, Mark Anderson, Bechara Mezher, Ernest Ribera, William Basri, Samuel Mourani, Benjamin Thomas, Harvey Allen, Andrew Cummins, Alexander Brun, Stephanie Abbott, Frederick Ruthardt, Michael Frankel, Sanjib Mohanty, Jason Taylor, Leonard Weinstock, Carl Wallach, Robert Strzinek, Mark McKenzie, Phillip Kiyasu, Ugochukwu Nwokoro, Humberto Aguilar, Craig Deligdish, Harvey Tatum, Glenn Littenberg, Dwight Blake, Jennifer Christie, Brian Webster, Isaac Bassan, Anjali Morey, Guy Strauss, Niaz Usman, Jeffrey Rosen, Priyesh Mehta, Dana Pan, Michael Hassman, Bryson Katona, Jyothi Mann, Jawahar Taunk, Cynthia Schaeffer, Lindsey Surace, Reid Ness, Ronnie Cyzner, Louis Lambiase, Endashaw Omer, Ben Ogunwale, Geetanjali Akerkar, John Baber, Howard Schwartz, Uma Mohan, William Fitzgibbons, Robyn Haithcock, Vinay Patel, Naveen Reddy, David Nemoto, Amit Gajera, Karen Simon, Scott Wofford, Shankar Thiruppathi, Steven Geller, Maryam Sattari, Shahid Ali, Felix Tiongco, Jaime Mayoral, Michael Rausch, Sunildat Maheshwari, Gowrappala Ramesh, John Hill, Strick Woods, Robert Barish, Sean Hunt, Neil Sengupta, Subhash Gumber, Eva Beaulieu, David Neumann, Michael Marsh, Mouhamad Al-Sabbagh, Christopher Connolley, Saleem Desai, Krishnamurthy Shivshanker, Ramkrishna Surendran, Christopher Ferris, Ayub Hussain, Harold Preiksaitis, Craig Eagle, Douglas Young, Frances Jones, Charles Baum, Joshua Oaks, Taddesa Desta, Moussab Tabbaa, Phillip Chen, Homan Abdollahzadeh, Gerald Simoni, Ronaldo Longoria, Francis McCormick, Hassam Aazami, Joseph Davis, Sunil Patel, Pendam Enayati, Matt Mason, Shahab Ud Din, Raja Mohi-ud-din, Vishnu Reddy, Larry Clark, Luis Lopez, Michael Brown, Moustafa Moustafa, Kim Turgeon, Bal Raj Bhandari, Promila Banerjee, Kamran Ayub
Related Therapeutic Areas
Sponsors
Collaborators: Premier Research Group plc
Leads: Guardant Health, Inc.

This content was sourced from clinicaltrials.gov

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