Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Colonoscopie versus stoelgangtesten voor colonpoliepen bij oudere volwassenen (COOP)

29 september 2026 bijgewerkt door: Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center

Colonoscopie versus op ontlasting gebaseerde tests voor oudere volwassenen met een voorgeschiedenis van colonpoliepen

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

6434

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar tot 82 jaar (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: FIT

FIT (annual)
Diagnostische toets: FIT

Annual FIT
Actieve vergelijker: Colonoscopy

Surveillance colonoscopy (one time)
Diagnostische toets: Colonoscopy

One time surveillance colonoscopy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dartmouth-Hitchcock Medical Center

Medewerkers

Patient-Centered Outcomes Research Institute

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 juni 2023

Primaire voltooiing (Geschat)

31 mei 2030

Studie voltooiing (Geschat)

31 december 2035

Studieregistratiedata

Eerst ingediend

4 november 2022

Eerst ingediend dat voldeed aan de QC-criteria

4 november 2022

Eerst geplaatst (Werkelijk)

10 november 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY02001984
  • PLACER-2020C3-20955 (Ander subsidie-/financieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren