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Coloscopie vs test des selles pour les polypes du côlon chez les personnes âgées (COOP)

29 septembre 2026 mis à jour par: Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center

Colonoscopie versus test basé sur les selles pour les personnes âgées ayant des antécédents de polypes du côlon

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

6434

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5A1
        • Recrutement
        • University of Calgary
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recrutement
        • University of British Columbia
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3EOW3
        • Recrutement
        • University of Manitoba
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recrutement
        • London Health Sciences Centre Research Institute
        • Contact:
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Actif, ne recrute pas
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, États-Unis, 85719
        • Recrutement
        • University of Arizona
        • Contact:
    • California
      • San Diego, California, États-Unis, 92161
        • Recrutement
        • Jennifer Moreno Department of Veterans Affairs Medical Cneter
        • Contact:
          • Dr. Samir Gupta
      • Walnut Creek, California, États-Unis, 94596
        • Recrutement
        • Kaiser Permanente Northern California
        • Contact:
    • Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20010
        • Recrutement
        • MedStar Health
        • Chercheur principal:
          • Jennifer Tran, MD
        • Contact:
    • Florida
      • Tampa, Florida, États-Unis, 33612-4745
        • Recrutement
        • James A. Haley Veterans Hospital
        • Contact:
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Northwestern Memorial Hospital
        • Chercheur principal:
          • Rajesh Keswani, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Recrutement
        • Richard L. Roudebush VA Medical Center
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48105
        • Recrutement
        • University of Michigan Health
        • Contact:
        • Chercheur principal:
          • Stacy Menees, MD
      • Detroit, Michigan, États-Unis, 48202
        • Recrutement
        • Henry Ford
        • Contact:
          • Dr. Suraj Suresh, MD
          • Numéro de téléphone: 313-932-5502
          • E-mail: SSuresh1@hfhs.org
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University School of Medicine
        • Contact:
          • Dr. Cassandra Fritz, MD
          • Numéro de téléphone: (314) 374-8335
          • E-mail: cfritz@wustl.edu
    • New Hampshire
      • Lebanon, New Hampshire, États-Unis, 03756
        • Recrutement
        • Dartmouth Health
        • Contact:
    • New York
      • New York, New York, États-Unis, 10010
    • North Carolina
      • Charlotte, North Carolina, États-Unis, 28204
        • Recrutement
        • Wake Forest University Health Sciences
        • Contact:
    • Oregon
      • Portand, Oregon, États-Unis, 97232
        • Résilié
        • Kaiser Permanente Northwest
      • Portland, Oregon, États-Unis, 97239
        • Recrutement
        • Oregon Health & Science University (Knight Cancer Institute)
        • Contact:
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • Recrutement
        • University of Utah
        • Contact:
        • Contact:
          • Lynette Holman
      • Sandy City, Utah, États-Unis, 84094
        • Recrutement
        • Intermountain Health
        • Contact:
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22903
        • Recrutement
        • University of Virginia Health
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans à 82 ans (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: FIT

FIT (annual)
Test diagnostique: FIT

Annual FIT
Comparateur actif: Colonoscopy

Surveillance colonoscopy (one time)
Test diagnostique: Colonoscopy

One time surveillance colonoscopy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dartmouth-Hitchcock Medical Center

Collaborateurs

Patient-Centered Outcomes Research Institute

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 juin 2023

Achèvement primaire (Estimé)

31 mai 2030

Achèvement de l'étude (Estimé)

31 décembre 2035

Dates d'inscription aux études

Première soumission

4 novembre 2022

Première soumission répondant aux critères de contrôle qualité

4 novembre 2022

Première publication (Réel)

10 novembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY02001984
  • PLACER-2020C3-20955 (Autre subvention/numéro de financement: Patient-Centered Outcomes Research Institute (PCORI))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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