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NCT04136002
Evaluación del test ctDNA LUNAR en un episodio de cribado en pacientes de riesgo promedio.
Activo, No Reclutando
Descripción
El estudio ECLIPSE (Evaluación de la prueba ctDNA LUNAR en un episodio de detección en una población de pacientes con riesgo promedio) es un estudio prospectivo, observacional y multicéntrico sin aleatorización. El objetivo principal del estudio es evaluar las características de rendimiento de una prueba basada en sangre, ctDNA LUNAR-2, para detectar el cáncer colorrectal en una población con riesgo promedio relevante para la detección.
Evidencia de la diana molecular en cáncer colorrectal
Estos fármacos NO son el fármaco de este ensayo. Es la eficacia publicada de OTROS fármacos que atacan la misma diana molecular, mostrada como contexto — no se refiere a este ensayo concreto ni confirma elegibilidad. Revísalo siempre con tu oncólogo.
Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.
Criterios de Elegibilidad
Criterios de inclusión:
1. Sujetos de entre 45 y 84 años en el momento del consentimiento.
2. Que tengan previsto someterse a una colonoscopia de cribado.
3. Considerados por un médico o profesional sanitario como de "riesgo promedio" para el CCRC.
4. Dispuestos a dar su consentimiento para la extracción de sangre antes de la administración de la preparación intestinal, antes de someterse a la colonoscopia en un plazo de 60 días a partir de la fecha de la extracción de sangre para el estudio.
5. Dispuestos a dar su consentimiento para el seguimiento durante dos años, según el protocolo.
Criterios de exclusión:
1. Sometidos a colonoscopia para la investigación de síntomas.
2. Que se hayan sometido a una colonoscopia en los 9 años anteriores.
3. Resultado positivo en la prueba de sangre oculta en heces (FIT/FOBT) en los 6 meses anteriores.
4. Que hayan completado las pruebas Cologuard o Epi proColon en los 3 años anteriores.
5. Antecedentes de cáncer colorrectal.
6. Antecedentes de cualquier neoplasia (los pacientes que se hayan sometido a la extirpación quirúrgica de un carcinoma de células escamosas de la piel pueden ser incluidos, siempre que el procedimiento se haya completado al menos 12 meses antes de la fecha en que se proporcione el consentimiento informado para el estudio).
7. Diagnóstico conocido de enfermedad inflamatoria intestinal.
8. Que estén tomando actualmente algún fármaco antineoplásico o inmunomodulador antirreumático (DMARD).
9. Antecedentes familiares de cáncer colorrectal, definidos como tener uno o más familiares de primer grado (padre, hermano o hijo) con CCRC a cualquier edad.
10. Riesgo hereditario/germinal conocido de cáncer colorrectal (por ejemplo, síndrome de Lynch o cáncer colorrectal hereditario no polipósico [HNPCC], o poliposis adenomatosa familiar [FAP]).
11. Cualquier traumatismo físico importante (por ejemplo, disrupción de los tejidos, cirugía, trasplante de órganos, transfusión de productos sanguíneos) en los 30 días previos a la obtención del consentimiento informado.
12. Alguna condición médica conocida que, en opinión del investigador, deba impedir la inclusión en el estudio.
13. Participación en un estudio de investigación clínica en el que se haya administrado o pueda administrarse un medicamento experimental en los 30 días previos a la obtención del consentimiento informado o que pueda administrarse durante el tiempo que dure la colonoscopia.
Información del Ensayo
NCT04136002
Activo, No Reclutando
Sin fase definida
44467 participantes
Oct 2019
Mar 2024
Ubicaciones271
United States (271)
Lovelace Scientific Resources, Inc.
Albuquerque
Eastern Pennsylvania GI & Liver Specialists
Allentown
US Digestive Health at Blair
Altoona
Associated Gastroenterology Medical Group
Anaheim
University of Michigan
Ann Arbor
Pinnacle Research Group, LLC
Anniston
InSite Digestive Health Care
Arcadia
Digestive Health Partners
Asheville
Digestive Health Care of Georgia
Atlanta
Emory University School of Medicine
Atlanta
Metro Atlanta Gastroenterology, LLC.
Atlanta
Elligo Clinical Research Center
Austin
Innovative Medical Research of South Florida, Inc.
Aventura
Gastroenterology Associates of Cleveland
Beachwood
Valley Gastroenterology Associates
Beaver Falls
Dayton Gastroenterology
Beavercreek
Dayton Gastroenterology, Inc.
Beavercreek
Washington Gastroenterology
Bellevue
Hassman Research Institute
Berlin
Progressive Clinical Research
Bountiful
Reciomed Clinical Research Network, Inc.
Boynton Beach
Allied Health Clinical Research Organization, LLC
Brick
Gastroenterology Associates of Fairfield County
Bridgeport
NY Scientific
Brooklyn
Sam Moskowitz, MD
Brooklyn
Gastroenterology
Burlingame
Ventura County Gastroenterology Medical Group
Camarillo
Associated Gastroenterologists of Central New York, Camillus
Camillus
Susquehanna Research Group, LLC
Camp Hill
Alliance Research Institute
Canoga Park
Hope Clinical Research
Canoga Park
Cary Gastro Associates
Cary
Christie Clinic
Champaign
Hope Research Institute
Chandler
Southeast Valley Gastroenterology
Chandler
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
Charlottesville Medical Research
Charlottesville
Erlanger Health Clinical Resarch
Chattanooga
WR-ClinSearch, LLC
Chattanooga
Digestive Health Specialists
Chelmsford
Gastroenterology Associates of Tidewater
Chesapeake
Clinical Research Professionals, LLC
Chesterfield
Curebase
Chicago
University of Chicago Medicine
Chicago
Gastro SB Clinic
Chula Vista
Precision Research Institute
Chula Vista
Gastro Health Research
Cincinnati
University of Cincinnati
Cincinnati
Gastroenterology Associates Of New Jersey
Clifton
Gastro Center of Maryland
Columbia
ClinOhio Research Services
Columbus
Columbus Regional Research Institute
Columbus
Gastroenterology Associates of Mississippi
Columbus
Carolina Digestive Health Associates, PA
Concord
Northeast GI Research Division
Concord
Clinical Research of South Florida, an AMR Company
Coral Gables
Northlake Gastroenterology Associates
Covington
GIMED Associates, Inc.
Cranston
Tri-State Gastroenterology Associates
Crestview Hills
Allied Digestive Disease Center
Cypress
Northside Gastroenterology Associates
Cypress
Uma Mohan MD PA
Cypress
Advance Clinical Research
Dayton
META Medical Research Institute
Dayton
Dolphin Medical Research
Doral
Digestive Health Services
Downers Grove
Curebase
Eagan
Associated Gastroenterology of Central New York
East Syracuse
Alliance for Multispecialty Research, LLC
El Dorado
El Paso Integrated Physicians Group, P.A.
El Paso
Skyline Medical Center, PC/CCT Research
Elkhorn
Centennial Medical Group
Elkridge
BG Clinical Research and affiliate of The Clinical Trials Network, LLC
Encinitas
Diagnamics, Inc
Encinitas
Gastroenterology Consultants of Augusta
Evans
Western Washington Medical Group, Inc
Everett
Verity Research
Fairfax
Lillestol Research, LLC
Fargo
Plains Clinical Research Center, LLC
Fargo
Associated Gastroenterologists of Central New York
Fayetteville
Coastal Research Institute, LLC
Fayetteville
AIG Digestive Disease Research
Florham Park
Frederick Gastroenterology Associates
Frederick
Allied Health Clinical Research Organization, LLC
Freehold
Intercity Gastroenterology
Fresh Meadows
Helping Hands Healthcare Group
Fullerton
University of Florida College of Medicine
Gainesville
Paragon RX Clinical, Inc.
Garden Grove
Gastro One
Germantown
Prime Medical Group, LLC
Gilbert
Hope Research Institute
Glendale
Mid-Atlantic GI Research
Greenbelt
Medication Management LLC
Greensboro
Digestive Disease Research Center
Greenwood
Lakeview Clinical Research
Guntersville
Hackensack Digestive Disease Associates
Hackensack
CMR of Greater New Haven, LLC
Hamden
Northlake Gastroenterology Associates
Hammond
Susquehanna Research Group
Harrisburg
Palmetto Research, LLC
Hialeah
Digestive Healthcare Center
Hillsborough
Edward Hines Jr. VA Hospital
Hines
Research Centers of America
Hollywood
The Center for Gastrointestinal Disorders
Hollywood
CroNola LLC
Houma
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
Digestive Health Research of Southern California
Huntington Beach
Medical Affiliated Research Center
Huntsville
Protenium Clinical Research Inc.
Hurst
University of Iowa Hospitals and Clinics
Iowa City
United Medical Doctors
Irvine
Allied Health Clinical Research Organization
Jackson
Helios Clinical Research lLC
Jackson
Southern Therapy and Advanced Research
Jackson
The Jackson Clinic
Jackson
The Jackson Clinic, PA
Jackson
Jasper Summit Research LLC
Jasper
East Tennessee Research Institute
Johnson City
Health Awareness, Inc
Jupiter
Jupiter Medical Center
Jupiter
Tri-Cities Gastroenterology
Kingsport
Gastrointestinal Associates, P.C.
Knoxville
Gastroclinic
Lafayette
Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research
Lake Barrington
Clinical Trials of SWLA, LLC
Lake Charles
Multi-Specialty Research Associates
Lake City
University Clinical Research-DeLand, LLC dba Accel Research Sites
Lake Mary
Florida Research Institute
Lakewood Rch
Gastro Care Institute
Lancaster
Excel Clinical Research
Las Vegas
Wr-Crcn, Llc
Las Vegas
South Island Gastro
Lawrence
SKY Clinical Research Network Group
Lawrenceville
Preferred Research Partners, Inc
Little Rock
Premier Gastroenterology
Little Rock
Gastroenterology Associates of Beverly Hills
Los Angeles
LA Gastroenterology Group
Los Angeles
University of Southern California
Los Angeles
Robley Rex VA Medical Center
Louisville
University of Louisville Research Foundation
Louisville
Blue Ridge Medical Research
Lynchburg
Holy Family Memorial, Inc
Manitowoc
East End Gastroenterology & Hepatology
Manorville
Biopharma Informatic
McAllen
University Clinical Research-DeLand, LLC dba Accel Research Sites
Melbourne
Great Lakes Gastroenterology
Mentor
Crystal Biomedical Research
Miami Lakes
Medical College of Wisconsin
Milwaukee
Delta Research Partners
Monroe
Gastroenterology Associates Of New Jersey
Montclair
Coastal Carolina Research Center
Mt. Pleasant
Suburban Gastroenterology Ltd
Naperville
GIMED Associates, Inc.
Narragansett
Vanderbilt University Medical Center
Nashville
Gastrointestinal Associates of Rockland
New City
Yale University
New Haven
Southeast Medical Research/Elms Research
North Charleston
Arkansas Gastroenterology
North Little Rock
Comprehensive Gastrointestinal Health
Northbrook
DM Clinical Research
Oak Lawn
Ocala GI Research, LLC
Ocala
Sarkis Clinical Trials
Ocala
Dr. Howard N. Guss and Dr. Gagan Beri
Ocean City
Advanced Research Institute
Ogden
Digestive Disease Specialists, Inc
Oklahoma City
Midwest Regional Health Services, LLC/CCT Research
Omaha
Knowledge Research Center
Orange
Gastroenterology of Greater Orlando
Orange City
South Carolina Clinical Research LLC
Orangeburg
Gastroenterology Institute of Orlando
Orlando
InSite Digestive Health Care-San Gabriel
Oxnard
Advanced Gastroenterology Associates, LLC
Palm Harbor
Desert Oasis Healthcare Medical Group
Palm Springs
Palm Tree Clinical, Inc
Palm Springs
Gastroenterology Consultants, P.A.
Pasadena
InSite Digestive Health Care - Gastroenterology Associates
Pasadena
Einstein Medical Center Department of Digestive Disease and Transplantation
Philadelphia
Perelman Center for Advanced Medicine
Philadelphia
"Forty-Third Medical Associates Absolute Clinical Research"
Phoenix
GI Research Associates, LLC
Phoenix
Pinehurst Medical Clinic
Pinehurst
Fanno Creek Group
Portland
The Oregon Clinic - Gastroenterology East
Portland
Carolina's GI Research, LLC
Raleigh
PMG Research of Raleigh
Raleigh
Advanced Research Institute
Reno
Gastroenterology Consultants
Reno
Gastroenterology Consultants
Reno
The Gastroenterology Group
Reston
GI Select Health Research, LLC
Richmond
Smart Medical Research
Richmond Hill
Quinn Healthcare
Ridgeland
Gastroenterology Associates Of New Jersey
Ridgewood
Infinite Clinical Trials
Riverdale
Onyx Clinical Research
Rochester Hills
Rockford Gastroenterology Associates, Ltd.
Rockford
Meridian Clinical Research
Rockville
Boice Willis Clinic, PA
Rocky Mount
Northern California Research
Sacramento
Covenant HealthCare
Saginaw
Digestive Health Specialists, LLC
Saint Joseph
PMG Research of Salisbury, LLC
Salisbury
Clinical Associates in Research Therapeutics of America
San Antonio
Medical Associates Research Group
San Diego
Precision Research Institute
San Diego
San Diego Gastroenterology Medical Associates
San Diego
SDG Clinical Research, Inc.
San Diego
Advanced Research Institute Granite Peaks Gastroenterology
Sandy City
WR-Mount Vernon Clinical Research, LLC
Sandy Springs
West Glen Gastrointestinal Consultants, P.A.
Shawnee
Gastroenterology Partners of North Houston
Shenandoah
Louisiana Research Center, LLC
Shreveport
Digestive Research Alliance of Michiana
South Bend
South Suburban Gastroenterology
South Weymouth
Revive Research Institute, LLC
Southfield
Velocity Clinical Research
Spokane
Texas Gastroenterology Associates/A1 Clinical Network
Spring
DSI Research, LLC
Springboro
Saint Louis University GI & Hepatology Research Unit
St Louis
Sundance Clinical Research
St Louis
Washington University School of Medicine Gastroenterology
St Louis
Piedmont HealthCare, PA
Statesville
GI Associates
Stevens Point
Gastroenterology Associates of Texas, PA
Sugar Land
PPCP Division of Gastroenterology LLC
Summerville
Precision Clinical Research, LLC
Sunrise
Syracuse Gastro Associates
Syracuse
Guardian Angel Research Center, LLC
Tampa
Teaneck Gastroenterology Associates
Teaneck
FOMAT Simoni AGI Medical
Thousand Oaks
University of Toledo Internal Medicine Clinic
Toledo
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc
Toluca Lake
Texas Gastro Consultants
Tomball
Clinical Research Institute of Michigan, LLC
Troy
Del Sol Research Management, LLC
Tucson
Novak Clinical Research
Tucson
Options Health Research, LLC
Tulsa
Del Sol Research Management, LLC
Tuscon
Advanced Gastroenterology Group
Union
Advanced Gastroenterology
Union City
Rolphe Adult and Pediatric Medicine
Union City
Frontier Clinical Research, LLC
Uniontown
Digestive Disease Medicine Of Central New York
Utica
GastroCare LI
Valley Stream
Clinical Research of California
Walnut Creek
Curebase
Walnut Creek
Gastrointestinal Specs Lng Is
Wantagh
Avamar Gastroenterology and Center
Warren
GI Associates
Wausau
Gastroenterology Associates Of New Jersey
Wayne
North Jersey Gastroenterology
Wayne
Invocare Medical Research & Healthcare Center
West Columbia
Eric L. Tatar, MD
West Nyack
Northshore Gastroenterology & Endoscopy Center
Westlake
Alliance for Multispecialty Research-Wichita West
Wichita
Kansas Gastroenterology, LLC
Wichita
Digestive Health Research of North Texas
Wichita Falls
Tidewater Physicians Multispecialty Group Clinical Research
Williamsburg
Trial Management Associates, LLC
Wilmington
Wilmington Health
Wilmington
PMG Research of Winston
Winston-Salem
Gastroenterology Associates Of New Jersey
Woodland Park