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Koloskopi vs avføringstesting for eldre voksne Kolonpolypper (COOP)

29. september 2026 oppdatert av: Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center

Koloskopi versus avføringsbasert testing for eldre voksne med en historie med kolonpolypper

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

6434

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år til 82 år (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: FIT

FIT (annual)
Diagnostisk test: FIT

Annual FIT
Aktiv komparator: Colonoscopy

Surveillance colonoscopy (one time)
Diagnostisk test: Colonoscopy

One time surveillance colonoscopy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dartmouth-Hitchcock Medical Center

Samarbeidspartnere

Patient-Centered Outcomes Research Institute

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. juni 2023

Primær fullføring (Antatt)

31. mai 2030

Studiet fullført (Antatt)

31. desember 2035

Datoer for studieregistrering

Først innsendt

4. november 2022

Først innsendt som oppfylte QC-kriteriene

4. november 2022

Først lagt ut (Faktiske)

10. november 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY02001984
  • PLACER-2020C3-20955 (Annet stipend/finansieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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