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NCT05080673ClinicalTrials.gov

Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

RecruitingTaking participants now, according to the registry record.
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In brief

This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Interventional9,500 participants sought493 sites2 countries

Categories

Oncology83%Gastroenterology & hepatology17%

Registered in 1 registry

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2021-10-18; recorded start 2022-02-09
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 49 other studies in this databaseCounted from the lead sponsor named in the record (NRG Oncology)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: other.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 485 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 9,500 participants (target), run at 493 sites, across 2 countries.

How this score is built
  • Enrolment38/40

    9,500 participants (target)

  • Site count25/25

    485 sites

  • Country count7/15

    2 countries

  • Planned duration10/10

    Planned over about 532 months

  • Sponsor scale6/10

    NRG Oncology has led 49 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Colorectal cancer (CRC) is the fourth most common cancer and the second leading cause of cancer death among men and women in the United States (US). The lifetime risk of colorectal cancer in both men and women in the US is approximately 6%. About 93% of colorectal cancer (CRC) diagnoses are in patients older than 50 years (Siegel 2014). Randomized controlled trials show that screening for CRC significantly decreases CRC incidence and mortality (Schoen 2012, Atkin 2010, Mandel 1999, Mandel 2000). CRC screening has received a Grade A recommendation from the US Preventive Services Task Force. In the U.S., colonoscopy is the most utilized screening modality for CRC. On a population basis, screening rates, which were around 40-50%, have now increased to 65%, and a goal to increase to 80% compliance is being promoted (CDC 2011, CDC 2013, Meester 2015). Adenomatous polyps are the acknowledged precursors of colorectal cancer. Identification and removal of adenomas is the mechanism by which screening is effective in reducing CRC incidence and subsequent mortality. "Advanced" adenomas are adenomas which are greater than or equal to 1 cm, or have a "villous" component (tubulovillous or villous), or have foci of high grade dysplasia. Advanced adenomas are associated with increased long-term risk of cancer, even years after colonoscopy (Click 2018). The prevalence of advanced adenomas at screening colonoscopy is 5-10% (Ferlitsch 2011, Imperiale 2014). Non-advanced adenomas are adenomas greater than 1 cm with neither villous components nor high grade dysplasia. Non-advanced adenomas are much more common than advanced adenomas, present in around 30% of colonoscopy exams (Ferlitsch 2011, Imperiale 2014). After detection of adenomas, patients are advised to return periodically for surveillance colonoscopy. Patients with 1-2 non-advanced adenomas are recommended by guidelines to return in 5 - 10 years for follow-up surveillance colonoscopy (Lieberman 2012). However, there are no guidelines on how to triage individuals to 5 as opposed to 10 years. Furthermore, there is limited evidence supporting the effectiveness of surveillance colonoscopy in reducing CRC incidence. A retrospective study in patients with advanced adenomas demonstrated benefit (Atkin 2017), but the study was not randomized and did not include patients with 1-2 non-advanced adenomas. The only randomized trial of surveillance colonoscopy was reported in the early 1990's, when participants were randomized to 3 vs. 1- and 3- year surveillance (Winawer 1993). No difference in advanced adenoma detection was observed when comparing participants examined at the two screening intervals, and as a result, guidelines were modified with participants advised to return every 3 years after adenomatous polyp detection. The recommended interval for non-advanced adenomas was gradually lengthened to the current standard, but there is no randomized, controlled data to support that interval. Furthermore, observational data of surveillance colonoscopy practice in the U.S. demonstrate that recommended intervals are often not adhered to, and individuals return for repeat testing well ahead of guideline recommendations (Schoen 2010, Lieberman 2014). Furthermore, if anything, retrospective, natural history studies of non-advanced adenomas do not support the association of non-advanced adenoma with a higher risk of subsequent colorectal cancer (Atkin 1992, Spencer 1984, Loberg 2014). For example, in a classic study from the United Kingdom, patients with small rectosigmoid adenomas, even if multiple, did not have an increased risk of CRC compared to the general population, over a 14-year mean follow-up time (Atkin 1992). In a recent observational study from Norway, participants with a low-risk adenoma followed over a median of 7.7 years (maximum 19 years) without subsequent surveillance colonoscopy, had a lower CRC mortality than the general population (Loberg 2014), implying that although the initial colonoscopy may be protective, subsequent follow-up colonoscopy was not required. More recently, several studies have reported that individuals with non-advanced adenomas do not have an increased risk of colorectal cancer compared to those with no adenomas (Click 2018, Lieberman 2019, Lee 2019). Another recent major development affecting screening is that practitioners of colonoscopy are now recommended to monitor and insure their adenoma detection rates are high. Data from Poland (Kaminski 2010) and Kaiser Permanente in California (Corley 2014) have demonstrated that a higher adenoma detection rate (ADR) is associated with a lower long-term risk of interval CRC, or cancer occurring after colonoscopy. Our understanding of these observations is premised on the notion that leaving pre-neoplastic tissue (adenomas) in situ, (such as what occurs with a lower ADR), increases the chance that an adenoma left behind will subsequently transform into cancer. The concern over interval cancers has stimulated quality concerns about the practice of colonoscopy. Guidelines for a recommended ADR at screening colonoscopy are rising, from the initial targets of 15% in women and 25% in men (Lieberman 2012) to 20% in women and 30% in men or 25% overall. ADRs in clinical studies are now commonly over 30% and some practitioners report rates exceeding 50%. However, adenomas that are detected when the ADR is high or as it increases over time are generally small, non-advanced adenomas. Current clinical practice favoring colonoscopy-based screening with increased emphasis on detection of adenomas, most of which will turn out to be small, non-advanced adenomas, will greatly increase demand for utilization of surveillance colonoscopy exams in the coming decades. Yet, the evidence for determining the benefit, optimal timing, and recommended frequency of surveillance colonoscopy is unknown. A randomized, clinical trial to demonstrate the difference in yield between 5- or 10-year surveillance for participants with non-advanced adenoma is needed to guide clinical practice. Only a randomized trial will be authoritative enough to define good clinical practice and directly influence clinical care.

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum

Eligibility

SexAll
Ages45 Years – 70 Years
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: * The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization. * Complete excision of all observed polyps in qualifying colonoscopy * Participants must be able to read or understand English or Spanish. Exclusion Criteria: * • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy. * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size. * Traditional serrated adenomas found on the qualifying colonoscopy. * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy. * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin. * Colonoscopy performed after the qualifying colonoscopy but prior to randomization. * Incomplete qualifying colonoscopy (e.g., cecum not visualized). * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.) * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.) * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age. * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]). * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer. * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis). * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator. * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationRandomised
Intervention modelPARALLEL
Primary purposeOTHER
MaskingNONE (0)
Enrolment9,500 participants sought

Sponsor and collaborators

  • NRG Oncology Sponsor
  • National Cancer Institute (NCI) Collaborators

Arms and interventions

  • Arm 1EXPERIMENTAL

    5-Year and 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

  • Arm 2EXPERIMENTAL

    10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

Interventions

  • Procedure 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

    The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.

Outcome measures

  1. Primary outcome

    Incidence of colorectal cancer

    To examine colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

    Time frame 10 years

  2. Other outcome

    Incidence of advanced adenoma

    To examine advanced adenoma incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

    Time frame 10 years

  3. Other outcome

    Colorectal cancer mortality

    To examine colorectal cancer mortality in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

    Time frame 10 years

  4. Other outcome

    Incidence of stage III-IV colorectal cancer

    To examine stage III-IV colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

    Time frame 10 years

Dates

Start dateFebruary 9, 2022 (actual)
Primary completionNovember 1, 2035 (estimated)
CompletionNovember 1, 2065 (estimated)
First postedOctober 18, 2021 (actual)
Last updatedSeptember 2, 2026
Results postedNot stated in the registry record
Status last verifiedSeptember 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

343 sites are recruiting

Puerto Rico

FacilityCityState or regionStatus
Cancer Center-Metro Medical Center BayamonBayamónRecruiting
Puerto Rico Hematology Oncology GroupBayamónRecruiting
HIMA San Pablo Oncologic HospitalCaguasSuspended
Pan American Center for Oncology Trials LLC - DoradoDoradoRecruiting
Doctors Cancer CenterManatiRecruiting
Pan American Center for Oncology Trials LLC - ManatiManatiRecruiting
Instituto Oncologia Moderna PoncePonceSuspended
Pan American Center for Oncology Trials LLC - CiudadelaSan JuanRecruiting
Primary Care Physician GroupSan JuanSuspended
PROncologySan JuanRecruiting
San Juan City HospitalSan JuanRecruiting
San Juan Community Oncology GroupSan JuanRecruiting
Centro Comprensivo de Cancer de UPRSan JuanRecruiting
Pan American Center for Oncology Trials LLCSan JuanRecruiting
San Juan Veterans Affairs Medical CenterSan JuanRecruiting

United States

FacilityCityState or regionStatus
Riverwood Healthcare CenterAitkinMinnesotaRecruiting
University of New Mexico Cancer CenterAlbuquerqueNew MexicoRecruiting
Lovelace Medical Center-Saint Joseph SquareAlbuquerqueNew MexicoSuspended
Saint Luke's Cancer Center - AllentownAllentownPennsylvaniaRecruiting
OSF Saint Anthony's Health CenterAltonIllinoisRecruiting
Community Hospital of AnacondaAnacondaMontanaRecruiting
Kaiser Permanente-AnaheimAnaheimCaliforniaRecruiting
University of Michigan Rogel Cancer CenterAnn ArborMichiganActive, not recruiting
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-AppletonAppletonWisconsinActive, not recruiting
PCR OncologyArroyo GrandeCaliforniaRecruiting
Mission Hope Medical Oncology - Arroyo GrandeArroyo GrandeCaliforniaRecruiting
Duluth Clinic AshlandAshlandWisconsinRecruiting
Northwest Wisconsin Cancer CenterAshlandWisconsinRecruiting
Piedmont HospitalAtlantaGeorgiaActive, not recruiting
Augusta University Medical CenterAugustaGeorgiaRecruiting
Rocky Mountain Regional VA Medical CenterAuroraColoradoRecruiting
Rush-Copley Medical CenterAuroraIllinoisActive, not recruiting
UCHealth University of Colorado HospitalAuroraColoradoRecruiting
Rocky Mountain Cancer Centers-AuroraAuroraColoradoActive, not recruiting
Mount Sinai Comprehensive Cancer Center at AventuraAventuraFloridaRecruiting
Saint Alphonsus Cancer Care Center-Baker CityBaker CityOregonSuspended
Kaiser Permanente-Baldwin ParkBaldwin ParkCaliforniaRecruiting
Mercy Oncology and Hematology - Clayton-ClarksonBallwinMissouriRecruiting
Kaiser Permanente-Woodlawn Medical CenterBaltimoreMarylandRecruiting
CommonSpirit Saint Joseph Hospital - BardstownBardstownKentuckyRecruiting
Bronson Battle CreekBattle CreekMichiganRecruiting
Essentia Health - Baxter ClinicBaxterMinnesotaRecruiting
Bay Pines VA Healthcare SystemBay PinesFloridaRecruiting
UHHS-Chagrin Highlands Medical CenterBeachwoodOhioRecruiting
Beaufort Memorial HospitalBeaufortSouth CarolinaRecruiting
Indu and Raj Soin Medical CenterBeavercreekOhioActive, not recruiting
Kaiser Permanente-BellflowerBellflowerCaliforniaRecruiting
Sanford Joe Lueken Cancer CenterBemidjiMinnesotaRecruiting
Saint Luke's University Hospital-Bethlehem CampusBethlehemPennsylvaniaRecruiting
Billings Clinic Cancer CenterBillingsMontanaRecruiting

443 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 2, 2026

    Site added

    8 sites added (493 total)

    485493

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05080673