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Five or Ten Year Colonoscopy ...

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

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

9500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2065-11-01

Brief Summary

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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.

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Case Volume and Adenoma Rate During Screening Colonoscopy

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Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

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De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

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Detailed Description

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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

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Adenocarcinoma of the Colon Adenocarcinoma of the Rectum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Surveillance

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Intervention Type PROCEDURE

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.

Arm 2

10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

Group Type EXPERIMENTAL

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Intervention Type PROCEDURE

Interventions

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5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Schoen, MD

Role: STUDY_CHAIR

University of Pittsburgh

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United States Puerto Rico

Central Contacts

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Director, Department of Regulatory Affairs

Role: CONTACT

[email protected]

412-339-5300

Norman Wolmark, MD

Role: CONTACT

Facility Contacts

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Site Public Contact

Role: primary

[email protected]

907-458-3043

Site Public Contact

Role: primary

623-207-3000

Site Public Contact

Role: primary

[email protected]

702-384-0013

Site Public Contact

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[email protected]

720-874-1881

Site Public Contact

Role: primary

[email protected]

520-626-3358

Role: primary

888-798-0719

888-336-8262

Role: primary

203-937-3421 ext. 2832

Site Public Contact

Role: primary

[email protected]

240-632-4285

Site Public Contact

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202-444-2223

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[email protected]

406-969-6060

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[email protected]

406-969-6060

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406-969-6060

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312-864-5204

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708-226-4357

Site Public Contact

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[email protected]

618-899-1894

Site Public Contact

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844-793-0745

Site Public Contact

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219-310-2550

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219-924-8178

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888-446-3729

Site Public Contact

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785-270-4939

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[email protected]

913-588-3671

574-647-7370

Site Public Contact

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574-647-7370

Site Public Contact

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[email protected]

616-391-1230

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218-365-7900

Site Public Contact

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[email protected]

218-786-3308

Site Public Contact

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218-786-3308

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612-467-2800

Site Public Contact

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[email protected]

952-993-1517

Site Public Contact

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[email protected]

952-993-1517

Role: primary

218-568-4416

218-894-7870

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[email protected]

952-993-1517

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[email protected]

816-271-7937

Site Public Contact

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417-269-4520

Site Public Contact

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417-269-4520

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888-446-3729

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[email protected]

314-525-6042

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314-251-7066

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702-384-0013

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[email protected]

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702-851-4672

Site Public Contact

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[email protected]

702-384-0013

Site Public Contact

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[email protected]

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[email protected]

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973-971-5900

Site Public Contact

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[email protected]

505-272-0530

Site Public Contact

Role: primary

[email protected]

505-925-0348

Role: primary

701-234-6161

Site Public Contact

Role: primary

605-312-3320

Role: primary

610-776-4714

Role: primary

412-647-2811

Site Public Contact

Role: primary

[email protected]

800-275-6401

Role: primary

866-590-2976

Site Public Contact

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[email protected]

843-789-7020

Site Public Contact

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864-560-6104

Site Public Contact

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[email protected]

864-522-4317

Site Public Contact

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[email protected]

864-560-6104

Site Public Contact

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864-560-6812

Site Public Contact

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[email protected]

864-560-6104

Role: primary

877-469-5300

Role: primary

[email protected]

Site Public Contact

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[email protected]

804-628-6430

Site Public Contact

Role: primary

540-981-7377

Site Public Contact

Role: primary

[email protected]

240-632-4285

Role: primary

304-487-7515

Site Public Contact

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304-243-6442

Role: primary

[email protected]

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[email protected]

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800-782-8581

Site Public Contact

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[email protected]

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218-568-4416

Site Public Contact

Role: primary

608-256-1901 ext. 17007

Site Public Contact

Role: primary

Role: primary

[email protected]

Role: primary

787-763-1296

Other Identifiers

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NCI-2020-00733

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-CC005

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study

Case Volume and Adenoma Rate During Screening Colonoscopy

Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

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Detailed Description

Conditions

Study Design

Study Groups

Arm 1

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Arm 2

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Interventions

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Cancer Institute (NCI)

NRG Oncology

Responsible Party

Principal Investigators

Robert Schoen, MD

Locations

Fairbanks Memorial Hospital

CTCA at Western Regional Medical Center

Kingman Regional Medical Center

Cancer Center at Saint Joseph's

University of Arizona Cancer Center - Prevention Research Clinic

Mercy Hospital Fort Smith

CHI Saint Vincent Cancer Center Hot Springs

CARTI Cancer Center

Kaiser Permanente-Anaheim

Mission Hope Medical Oncology - Arroyo Grande

PCR Oncology

Kaiser Permanente-Baldwin Park

Kaiser Permanente-Bellflower

Mercy Cancer Center - Carmichael

Mercy San Juan Medical Center

Epic Care-Dublin

Mercy Cancer Center - Elk Grove

Bay Area Breast Surgeons Inc

Epic Care Partners in Cancer Care

Kaiser Permanente-Fontana

Kaiser Permanente South Bay

Kaiser Permanente-Irvine

Kaiser Permanente Los Angeles Medical Center

Kaiser Permanente West Los Angeles

UCLA / Jonsson Comprehensive Cancer Center

Contra Costa Regional Medical Center

Mercy Cancer Center

Alta Bates Summit Medical Center - Summit Campus

Bay Area Tumor Institute

Kaiser Permanente-Ontario

Stanford Cancer Institute Palo Alto

Kaiser Permanente - Panorama City

Kaiser Permanente-Riverside

Mercy Cancer Center - Rocklin

Mercy Cancer Center - Sacramento

Kaiser Permanente-San Diego Mission

Kaiser Permanente-San Diego Zion

Pacific Central Coast Health Center-San Luis Obispo

Kaiser Permanente-San Marcos

Mission Hope Medical Oncology - Santa Maria

Saint Joseph's Medical Center

Kaiser Permanente-Vallejo

Epic Care Cyberknife Center

BASS Medical Group - Lennon

Woodland Memorial Hospital

Kaiser Permanente-Woodland Hills

Rocky Mountain Cancer Centers-Aurora

Rocky Mountain Regional VA Medical Center

UCHealth University of Colorado Hospital

Boulder Community Foothills Hospital