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Colonoscopia vs Prueba de heces para adultos mayores Pólipos de colon (COOP)

29 de septiembre de 2026 actualizado por: Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center

Colonoscopia versus pruebas en heces para adultos mayores con antecedentes de pólipos en el colon

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Colon polyps are common among adults ≥50 years and people with colon polyps are recommended to undergo regular follow-up colonoscopy (surveillance) in hopes of preventing subsequent colorectal cancer (CRC). Older adults, particularly those who are age ≥70 years, most of whom have a history of only small colon polyps, may benefit little from repeated colonoscopies because of the increased risks of colonoscopy due to age and co-morbidities and potentially limited life expectancy due to other competing medical problems - CRC may never be a problem for them. Older adults may also be hesitant to get repeated colonoscopy because of the risk of complications (e.g., bleeding, perforation, etc.) and inconvenience. More surveillance options are needed to help address the concerns and challenges with repeated colonoscopies in older adults with a history of low-risk polyps.

FIT is a noninvasive, stool-based test that is recommended and widely used in the US and globally for CRC screening in average-risk adults 45 to 75 years of age. In addition, FIT is already standard of care as a surveillance option for patients with a history of low-risk adenomas in Canada and has been shown to be equivalent to colonoscopy for screening of certain high-risk populations (e.g., those with a family history of CRC). However, FIT's role for surveillance among older adults who have a history of low-risk adenomas has not been studied in the US nor among older adults who may benefit from this noninvasive surveillance approach.

The COOP Trial will fill this evidence gap and shed light on patient-, clinician-, and system-factors relevant to FIT for surveillance that together could potentially transform surveillance guidelines in the US and beyond

The purpose of this study is to compare annual at-home stool-based testing, with a fecal immunochemical test (FIT), to colonoscopy in adults age 65-82 who have a history of colorectal polyps. The goal of the study is to compare how well FIT works compared to colonoscopy in looking for and finding colorectal cancer in older adults who have a history of colorectal polyps, as well as to understand people's experiences with using it compared to colonoscopy.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

6434

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.

Estudio Contacto

Ubicaciones de estudio

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 5A1
        • Reclutamiento
        • University of Calgary
        • Contacto:
          • Dr. Robert Hilsden, MD
          • Número de teléfono: 403-592-5042
          • Correo electrónico: rhilsden@ucalgary.ca
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 1Y6
        • Reclutamiento
        • University of British Columbia
        • Contacto:
          • Dr. Jennifer Telford, MD
          • Número de teléfono: 6046886332
          • Correo electrónico: jtelford29@gmail.com
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3EOW3
        • Reclutamiento
        • University of Manitoba
        • Contacto:
    • Ontario
      • London, Ontario, Canadá, N6A 5W9
        • Reclutamiento
        • London Health Sciences Centre Research Institute
        • Contacto:
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Activo, no reclutando
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85719
        • Reclutamiento
        • University of Arizona
        • Contacto:
    • California
      • San Diego, California, Estados Unidos, 92161
        • Reclutamiento
        • Jennifer Moreno Department of Veterans Affairs Medical Cneter
        • Contacto:
          • Dr. Samir Gupta
      • Walnut Creek, California, Estados Unidos, 94596
        • Reclutamiento
        • Kaiser Permanente Northern California
        • Contacto:
    • Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Reclutamiento
        • MedStar Health
        • Investigador principal:
          • Jennifer Tran, MD
        • Contacto:
    • Florida
      • Tampa, Florida, Estados Unidos, 33612-4745
        • Reclutamiento
        • James A. Haley Veterans Hospital
        • Contacto:
          • Brijesh Patel, MD
          • Número de teléfono: (813) 619-5131
          • Correo electrónico: Kamryn.woods@va.gov
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Reclutamiento
        • Northwestern Memorial Hospital
        • Investigador principal:
          • Rajesh Keswani, MD
        • Contacto:
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Reclutamiento
        • Richard L. Roudebush VA Medical Center
        • Contacto:
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48105
        • Reclutamiento
        • University of Michigan Health
        • Contacto:
        • Investigador principal:
          • Stacy Menees, MD
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford
        • Contacto:
          • Dr. Suraj Suresh, MD
          • Número de teléfono: 313-932-5502
          • Correo electrónico: SSuresh1@hfhs.org
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Reclutamiento
        • Washington University School of Medicine
        • Contacto:
          • Dr. Cassandra Fritz, MD
          • Número de teléfono: (314) 374-8335
          • Correo electrónico: cfritz@wustl.edu
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Reclutamiento
        • Dartmouth Health
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10010
        • Reclutamiento
        • New York Harbor Health Care System - Dept of Veterans Affairs
        • Contacto:
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Reclutamiento
        • Wake Forest University Health Sciences
        • Contacto:
    • Oregon
      • Portand, Oregon, Estados Unidos, 97232
        • Terminado
        • Kaiser Permanente Northwest
      • Portland, Oregon, Estados Unidos, 97239
        • Reclutamiento
        • Oregon Health & Science University (Knight Cancer Institute)
        • Contacto:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Reclutamiento
        • University of Utah
        • Contacto:
        • Contacto:
          • Lynette Holman
      • Sandy City, Utah, Estados Unidos, 84094
        • Reclutamiento
        • Intermountain Health
        • Contacto:
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Reclutamiento
        • University of Virginia Health
        • Contacto:

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

65 años a 82 años (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • English or Spanish speaking
  • Personal history of colorectal polyps
  • Most recent colonoscopy with ≤2 non-advanced polyps
  • Currently due or coming due within 12 months for colonoscopy
  • Able to provide written informed consent

Exclusion Criteria:

  • Personal history of colorectal cancer
  • Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)
  • Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)
  • Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps
  • Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)
  • Patients unable to provide written informed consent

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: FIT

FIT (annual)
Prueba de diagnóstico: FIT

Annual FIT
Comparador activo: Colonoscopy

Surveillance colonoscopy (one time)
Prueba de diagnóstico: Colonoscopy

One time surveillance colonoscopy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of advanced neoplasia in each study group, annual FIT and colonoscopy, assessed by comparing the detection of advanced neoplasia between the two study groups.
Periodo de tiempo: Up to 11 years

The investigators will determine the incidence of advanced neoplasia, defined as adenocarcinoma of the colon or rectum or adenomas or serrated polyps ≥1 cm in size or with villous features or any dysplasia, or traditional serrated polyps, in both study groups through annual surveys asking about any changes in polyp history or new cancer diagnosis for up to 6 years and medical record review for up to 11 years. The incidence of advanced neoplasia will be compared between the two study group cumulatively after all the data has been collected.
Up to 11 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline Satisfaction and Trust of colorectal screening testing assessed by Tiro et al (2005) Response Efficacy sub-scale from the general colorectal cancer screening survey.
Periodo de tiempo: Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years

The Response Efficacy sub-scale from the general colorectal cancer screening survey is a 2 item scale with five response options (1=strongly disagree, 2=mildly disagree, 3=don't know, 4=mildly agree, 5=strongly agree), such that each individual attains a score ranging from 2 to 10.
Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years
Change from baseline worry about colorectal Cancer assessed by the Cancer Worry Scale (CWS)
Periodo de tiempo: Baseline and annually for up to 6 years

The Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).
Baseline and annually for up to 6 years
Change from baseline Perceived colorectal cancer susceptibility using Absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010)
Periodo de tiempo: Baseline, annually for up to 6 years

The absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010) is a three-question scale using four-point Likert format ranging from 1= strongly disagree to 4=strongly agree, such that each individual attains a score ranging from 3 (minimum susceptibility) to 12 (maximum susceptibility).
Baseline, annually for up to 6 years
Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)
Periodo de tiempo: Baseline and annually for up to 6 years

The PCQ is a 22 question scale that has four response options (1=Not at all, 2=a little bit, 3=quite a bit, 4=a great deal) such that each individual attains a score ranging from 22 to 88.
Baseline and annually for up to 6 years
Change from baseline perceived global health assessed by the Patient-Reported Outcomes Measurement Information System-Global 10
Periodo de tiempo: Baseline and annually for up to 6 years

The Patient-Reported Outcomes Measurement Information System-10 is a 10-item scale that has five response options (5=excellent, 4=very good, 3=good, 2=fair, 1=poor) which assess overall QOL. Raw scores are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed. Scoring supports two summary scores: A Global Physical Health (GPH) score and a Global Mental Health (GMH) score.
Baseline and annually for up to 6 years
Major and minor harms within 30 days of colonoscopy, as measured through chart review and telephone interview.
Periodo de tiempo: 30-45 days post colonoscopy for up to 6 years

Major and minor harms within 30 days of colonoscopy will be collected through chart review and a telephone interview with participants 30-45 post study surveillance colonoscopy or study colonoscopy for positive FIT. The incidence of harms will be compared between the study groups (annual FIT and colonoscopy).
30-45 days post colonoscopy for up to 6 years

Colaboradores e Investigadores

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

Patrocinador

Dartmouth-Hitchcock Medical Center

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

  • Investigador principal: Audrey H Calderwood, MD, MS, Dartmouth-Hitchcock Medical Center
  • Investigador principal: Theodore R Levin, MD, Kaiser Permante Northern California

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

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)

14 de junio de 2023

Finalización primaria (Estimado)

31 de mayo de 2030

Finalización del estudio (Estimado)

31 de diciembre de 2035

Fechas de registro del estudio

Enviado por primera vez

4 de noviembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

4 de noviembre de 2022

Publicado por primera vez (Actual)

10 de noviembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

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

29 de septiembre de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY02001984
  • PLACER-2020C3-20955 (Otro número de subvención/financiamiento: Patient-Centered Outcomes Research Institute (PCORI))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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