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Colonscopia vs test delle feci per i polipi del colon degli anziani (COOP)

29 settembre 2026 aggiornato da: Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center

Colonscopia contro test basati sulle feci per gli anziani con una storia di polipi del 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

6434

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5A1
        • Reclutamento
        • University of Calgary
        • Contatto:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Reclutamento
        • University of British Columbia
        • Contatto:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3EOW3
        • Reclutamento
        • University of Manitoba
        • Contatto:
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Reclutamento
        • London Health Sciences Centre Research Institute
        • Contatto:
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Attivo, non reclutante
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85719
        • Reclutamento
        • University of Arizona
        • Contatto:
    • California
      • San Diego, California, Stati Uniti, 92161
        • Reclutamento
        • Jennifer Moreno Department of Veterans Affairs Medical Cneter
        • Contatto:
          • Dr. Samir Gupta
      • Walnut Creek, California, Stati Uniti, 94596
        • Reclutamento
        • Kaiser Permanente Northern California
        • Contatto:
    • Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20010
        • Reclutamento
        • MedStar Health
        • Investigatore principale:
          • Jennifer Tran, MD
        • Contatto:
    • Florida
      • Tampa, Florida, Stati Uniti, 33612-4745
        • Reclutamento
        • James A. Haley Veterans Hospital
        • Contatto:
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Northwestern Memorial Hospital
        • Investigatore principale:
          • Rajesh Keswani, MD
        • Contatto:
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Reclutamento
        • Richard L. Roudebush VA Medical Center
        • Contatto:
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48105
        • Reclutamento
        • University of Michigan Health
        • Contatto:
        • Investigatore principale:
          • Stacy Menees, MD
      • Detroit, Michigan, Stati Uniti, 48202
        • Reclutamento
        • Henry Ford
        • Contatto:
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Washington University School of Medicine
        • Contatto:
          • Dr. Cassandra Fritz, MD
          • Numero di telefono: (314) 374-8335
          • Email: cfritz@wustl.edu
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Reclutamento
        • Dartmouth Health
        • Contatto:
    • New York
      • New York, New York, Stati Uniti, 10010
        • Reclutamento
        • New York Harbor Health Care System - Dept of Veterans Affairs
        • Contatto:
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Reclutamento
        • Wake Forest University Health Sciences
        • Contatto:
    • Oregon
      • Portand, Oregon, Stati Uniti, 97232
        • Terminato
        • Kaiser Permanente Northwest
      • Portland, Oregon, Stati Uniti, 97239
        • Reclutamento
        • Oregon Health & Science University (Knight Cancer Institute)
        • Contatto:
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • Reclutamento
        • University of Utah
        • Contatto:
        • Contatto:
          • Lynette Holman
      • Sandy City, Utah, Stati Uniti, 84094
        • Reclutamento
        • Intermountain Health
        • Contatto:
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22903
        • Reclutamento
        • University of Virginia Health
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 65 anni a 82 anni (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: FIT

FIT (annual)
Test diagnostico: FIT

Annual FIT
Comparatore attivo: Colonoscopy

Surveillance colonoscopy (one time)
Test diagnostico: Colonoscopy

One time surveillance colonoscopy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaboratori

Patient-Centered Outcomes Research Institute

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 giugno 2023

Completamento primario (Stimato)

31 maggio 2030

Completamento dello studio (Stimato)

31 dicembre 2035

Date di iscrizione allo studio

Primo inviato

4 novembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

4 novembre 2022

Primo Inserito (Effettivo)

10 novembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY02001984
  • PLACER-2020C3-20955 (Altro numero di sovvenzione/finanziamento: Patient-Centered Outcomes Research Institute (PCORI))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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