Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The National CT Colonography Trial (ACRIN6664)

30 de noviembre de 2020 actualizado por: American College of Radiology Imaging Network

The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population

RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.

PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia.

Secondary

  • Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations.
  • Determine the effects of different colon preparations on the accuracy of CTC in these participants.
  • Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
  • Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.

OUTLINE: This is a multicenter study.

Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy.

Participants are followed up for approximately 4 weeks.

PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2600

Fase

  • No aplica

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

  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259-5499
        • Mayo Clinic Scottsdale
    • California
      • La Jolla, California, Estados Unidos, 92093-0658
        • Moores UCSD Cancer Center
      • Los Angeles, California, Estados Unidos, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • San Francisco, California, Estados Unidos, 94121
        • Veterans Affairs Medical Center - San Francisco
    • Colorado
      • Englewood, Colorado, Estados Unidos, 80112
        • Invision/Radiology Imaging Associates - Englewood
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06520-8028
        • Yale Cancer Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637-1470
        • University of Chicago Cancer Research Center
      • Springfield, Illinois, Estados Unidos, 62781
        • Clinical Radiologists, S.C. at Memorial Medical Center
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Mallinckrodt Institute of Radiology at Washington University Medical Center
    • Texas
      • Houston, Texas, Estados Unidos, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center

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

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

  1. Inclusion Criteria

    • Male or female outpatients
    • Aged 50 years or older
    • Scheduled for screening colonoscopy
    • Participant's signed informed consent

  2. Exclusion Criteria

    • Symptoms of disease of the lower gastrointestinal tract, including

      • Melanotic stools or/and hematochezia on more than one occasion in the previous six months
      • Lower abdominal pain that would normally require a medical evaluation
    • Inflammatory bowel disease and/or familial polyposis syndrome
    • Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
    • Pregnancy
    • Previous colonoscopy within the past five years
    • Anemia (hemoglobin less than 10 gm/dl)
    • Positive fecal occult blood test (FOBT)

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

  • Propósito principal: Poner en pantalla
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
Procedimiento: CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Otros nombres:
  • colonoscopia
  • CT colonography trial

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
Periodo de tiempo: within 30 days

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

RS+: Colonoscopy found at least 1 Advanced adenomas >=10mm (as measured at pathology) RS-: No Advanced adenomas >=10mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
Periodo de tiempo: within 30 days

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

RS+: Colonoscopy found at least 1 Advanced adenomas >=9mm (as measured at pathology) RS-: No Advanced adenomas >=9mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)
Periodo de tiempo: within 30 days

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

RS+: Colonoscopy found at least 1 Advanced adenomas >=8mm (as measured at pathology) RS-: No Advanced adenomas >=8mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)
Periodo de tiempo: within 30 days

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

RS+: Colonoscopy found at least 1 Advanced adenomas >=7mm (as measured at pathology) RS-: No Advanced adenomas >=7mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient)
Periodo de tiempo: within 30 days

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

RS+: Colonoscopy found at least 1 Advanced adenomas >=6mm (as measured at pathology) RS-: No Advanced adenomas >=16mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient)
Periodo de tiempo: within 30 days

Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

RS+: Colonoscopy found at least 1 Advanced adenomas >=5mm (as measured at pathology) RS-: No Advanced adenomas >=5mm found by colonoscopy (as measured at pathology)
within 30 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)
Periodo de tiempo: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)
Periodo de tiempo: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)
Periodo de tiempo: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)
Periodo de tiempo: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)
Periodo de tiempo: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion)
Periodo de tiempo: within 30 days
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
within 30 days
Interobserver Sensitivity Variability
Periodo de tiempo: at baseline
Evaluate interobserver variability in Sensitivity (P(T+|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results. A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing
at baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

American College of Radiology Imaging Network

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: C. Daniel Johnson, MD, Mayo Clinic

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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

1 de febrero de 2005

Finalización primaria (Actual)

11 de septiembre de 2007

Finalización del estudio (Actual)

13 de mayo de 2010

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2004

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2004

Publicado por primera vez (Estimar)

11 de junio de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de diciembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

30 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000367101
  • U01CA080098 (Subvención/contrato del NIH de EE. UU.)
  • U01CA079778 (Subvención/contrato del NIH de EE. UU.)
  • ACRIN-6664 (Otro identificador: CIP)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Researchers may request data from the ACRIN data access committee by reviewing the information at:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

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

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. .

Ensayos clínicos sobre Cáncer colonrectal

Ensayos clínicos sobre CT Colonography

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Bulgaria

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir