Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
20 de julio de 2020 actualizado por: Exact Sciences Corporation
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy.
Approximately 7,500 subjects will be enrolled.
Tipo de estudio
De observación
Inscripción (Actual)
5131
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Tempe, Arizona, Estados Unidos, 85283
- CCT Research/Fiel Family and Sports Medicine
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California
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Chula Vista, California, Estados Unidos, 91910
- GW Research, Inc
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Huntington Beach, California, Estados Unidos, 92647
- Marvel Research, LLC
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Palm Springs, California, Estados Unidos, 92262
- Desert Medical Group Inc
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San Diego, California, Estados Unidos, 92103
- Great Lakes Medical Research, LLC
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06016
- Connecticut Clinical Research Institute, LLC
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Florida
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Tampa, Florida, Estados Unidos, 33614
- Guardian Angel Research Center
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Illinois
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Oak Lawn, Illinois, Estados Unidos, 60453
- DM Clinical Research/Southwest Gastroenterology
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Indiana
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Batesville, Indiana, Estados Unidos, 47006
- Margaret Mary Health
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Evansville, Indiana, Estados Unidos, 47725
- Deaconess Clinic-Mt. Pleasant
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Newburgh, Indiana, Estados Unidos, 47630
- Deaconess Clinic-Gateway
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- New Orleans Research Institute
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Monroe, Louisiana, Estados Unidos, 71201
- Delta Research Partners
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Shreveport, Louisiana, Estados Unidos, 71105
- Louisiana Research Center, LLC
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Maryland
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Elkridge, Maryland, Estados Unidos, 21075
- Centennial Medical Group
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Rockville, Maryland, Estados Unidos, 20850
- Capitol Research
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Michigan
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East Lansing, Michigan, Estados Unidos, 48823
- Great Lakes Medical Research, LLC
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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New Jersey
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Egg Harbor Township, New Jersey, Estados Unidos, 08234
- AGA Clinical Research Associates, LLC
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New York
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New Hyde Park, New York, Estados Unidos, 11040
- Digestive Disease Care, PC
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28801
- Digestive Health Partners, PA
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Charlotte, North Carolina, Estados Unidos, 28207
- Charlotte Gastroenterology and Hepatology, LLC
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Wilmington, North Carolina, Estados Unidos, 28403
- Trial Management Associates, LLC
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Ohio
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Beachwood, Ohio, Estados Unidos, 44122
- Great Lakes Medical Research
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Massillon, Ohio, Estados Unidos, 44647
- Family Practice Center of Wooster, Inc./Clinical Trial Developers
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Mentor, Ohio, Estados Unidos, 44060
- Great Lakes Gastroenterology Research, LLC
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Westlake, Ohio, Estados Unidos, 44145
- Great Lakes Medical Research, LLC
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Wooster, Ohio, Estados Unidos, 44691
- Comprehensive Internal Medicine, Inc
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 16506
- Great Lakes Medical Research
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Harrisburg, Pennsylvania, Estados Unidos, 17110
- Susquehanna Research Group
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Tennessee
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Union City, Tennessee, Estados Unidos, 38261
- Great Lakes Medical Research, LLC
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Texas
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Austin, Texas, Estados Unidos, 78726
- MediSync Clinical Research
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Cypress, Texas, Estados Unidos, 77429
- Northside Gastroenterology
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Houston, Texas, Estados Unidos, 77017
- Vilo Research Group, Inc
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Houston, Texas, Estados Unidos, 77024
- Digestive Health Associates
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Magnolia, Texas, Estados Unidos, 77355
- DM Clinical Research/PCP For Life
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Virginia
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Lynchburg, Virginia, Estados Unidos, 24502
- Blue Ridge Medical Research
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Suffolk, Virginia, Estados Unidos, 23434
- Virginia Gastroenterology Institute
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Washington
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Wenatchee, Washington, Estados Unidos, 98801
- Wenatchee Valley Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy.
Approximately 7,500 subjects will be enrolled.
Descripción
Inclusion Criteria:
- Subject is male or female, 40 years of age or older.
- Subject is at average or increased risk for development of CRC.
- Subject presents for screening or surveillance colonoscopy.
- Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
- Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
Subject has a diagnosis or personal history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.
Subject has a family history of:
- Familial adenomatous polyposis (also referred to as "FAP").
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- Subjects with Cronkhite-Canada Syndrome.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Average CRC Risk Group
Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure
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Increased CRC Risk Group
Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stool-based biomarkers associated with genetic and epigenetic alterations
Periodo de tiempo: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
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The outcomes are co-primary.
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
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Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
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Blood-based biomarkers associated with genetic and epigenetic alterations.
Periodo de tiempo: Point in time blood collection (1 day) at enrollment.
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The outcomes are co-primary.
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
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Point in time blood collection (1 day) at enrollment.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de enero de 2019
Finalización primaria (Actual)
28 de febrero de 2020
Finalización del estudio (Actual)
15 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
16 de enero de 2019
Primero enviado que cumplió con los criterios de control de calidad
25 de enero de 2019
Publicado por primera vez (Actual)
30 de enero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018-08
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification.
This may include text, tables, figures and appendices.
The study protocol and informed consent form will also be shared.
Marco de tiempo para compartir IPD
Data will be available from 2 years and ending 4 years after publication.
Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Criterios de acceso compartido de IPD
Proposals for access to data should be directed to clinicaltrials@exactsciences.com.
To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement.
Researchers are are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.
Data will available between 2 and 4 years after publication through the Sponsor.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .