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

April 15, 2024 updated by: NRG Oncology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

9500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Norman Wolmark, MD

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Cancer Center at Saint Joseph's
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Arroyo Grande, California, United States, 93420
      • Dublin, California, United States, 94568
        • Recruiting
        • Epic Care-Dublin
        • Contact:
          • Site Public Contact
          • Phone Number: 925-875-1677
        • Principal Investigator:
          • Lisa Bailey
      • Emeryville, California, United States, 94608
        • Recruiting
        • Bay Area Breast Surgeons Inc
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
          • Site Public Contact
          • Phone Number: 510-835-9900
      • Emeryville, California, United States, 94608
        • Recruiting
        • Epic Care Partners in Cancer Care
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
          • Site Public Contact
          • Phone Number: 510-629-6682
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Principal Investigator:
          • Folasade P. May
        • Contact:
          • Site Public Contact
          • Phone Number: 888-798-0719
      • Martinez, California, United States, 94553-3156
        • Recruiting
        • Contra Costa Regional Medical Center
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
          • Site Public Contact
          • Phone Number: 925-957-5400
      • Oakland, California, United States, 94609
        • Suspended
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94609
        • Recruiting
        • Bay Area Tumor Institute
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
      • San Luis Obispo, California, United States, 93401
      • Santa Maria, California, United States, 93444
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Principal Investigator:
          • Douglas A. Corley
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Walnut Creek, California, United States, 94597
        • Recruiting
        • Epic Care Cyberknife Center
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose-Saint Francis Healthcare
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Rocky Mountain Cancer Centers-Penrose
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Saint Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Porter Adventist Hospital
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Durango, Colorado, United States, 81301
        • Recruiting
        • Mercy Medical Center
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Durango, Colorado, United States, 81301
        • Recruiting
        • Southwest Oncology PC
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Saint Anthony Hospital
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Littleton Adventist Hospital
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Longmont, Colorado, United States, 80501
        • Recruiting
        • Longmont United Hospital
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Longmont, Colorado, United States, 80501
        • Recruiting
        • Rocky Mountain Cancer Centers-Longmont
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Parker, Colorado, United States, 80138
        • Recruiting
        • Parker Adventist Hospital
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Pueblo, Colorado, United States, 81004
        • Recruiting
        • Saint Mary Corwin Medical Center
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Active, not recruiting
        • Rush - Copley Medical Center
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Joshua E. Melson
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • John H Stroger Jr Hospital of Cook County
        • Contact:
          • Site Public Contact
          • Phone Number: 312-864-5204
        • Principal Investigator:
          • Thomas E. Lad
      • Danville, Illinois, United States, 61832
        • Active, not recruiting
        • Carle on Vermilion
      • Effingham, Illinois, United States, 62401
        • Active, not recruiting
        • Carle Physician Group-Effingham
      • Mattoon, Illinois, United States, 61938
        • Active, not recruiting
        • Carle Physician Group-Mattoon/Charleston
      • Urbana, Illinois, United States, 61801
        • Active, not recruiting
        • Carle Cancer Center
      • Urbana, Illinois, United States, 61801
        • Active, not recruiting
        • The Carle Foundation Hospital
      • Yorkville, Illinois, United States, 60560
        • Active, not recruiting
        • Rush-Copley Healthcare Center
    • Iowa
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Medical Oncology and Hematology Associates-West Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Council Bluffs, Iowa, United States, 51503
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Medical Oncology and Hematology Associates-Laurel
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Corbin, Kentucky, United States, 40701
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • London, Kentucky, United States, 40741
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40215
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Shepherdsville, Kentucky, United States, 40165
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Mercy Health Saint Mary's
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Ascension Borgess Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Borgess Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Mercy Health Mercy Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Lakeland Hospital Niles
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Spectrum Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Lakeland Medical Center Saint Joseph
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Metro Health Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
    • Minnesota
      • Aitkin, Minnesota, United States, 56431
        • Recruiting
        • Riverwood Healthcare Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Bemidji, Minnesota, United States, 56601
      • Brainerd, Minnesota, United States, 56401
        • Recruiting
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Fairview Ridges Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Detroit Lakes, Minnesota, United States, 56501
        • Recruiting
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Saint Mary's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Miller-Dwan Hospital
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Fergus Falls, Minnesota, United States, 56537
        • Recruiting
        • Lake Region Healthcare Corporation-Cancer Care
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Fosston, Minnesota, United States, 56542
        • Recruiting
        • Essentia Health - Fosston
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Fridley, Minnesota, United States, 55432
        • Recruiting
        • Unity Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Park Rapids, Minnesota, United States, 56470
        • Recruiting
        • Essentia Health - Park Rapids
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Thief River Falls, Minnesota, United States, 56701
        • Recruiting
        • Sanford Thief River Falls Medical Center
        • Principal Investigator:
          • Preston D. Steen
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Worthington, Minnesota, United States, 56187
        • Recruiting
        • Sanford Cancer Center Worthington
        • Principal Investigator:
          • Preston D. Steen
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
      • Kearney, Nebraska, United States, 68847
      • Lincoln, Nebraska, United States, 68510
      • Omaha, Nebraska, United States, 68122
      • Omaha, Nebraska, United States, 68124
      • Omaha, Nebraska, United States, 68130
      • Omaha, Nebraska, United States, 68131
      • Papillion, Nebraska, United States, 68046
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Principal Investigator:
          • Henry S. Dinneen
        • Contact:
          • Site Public Contact
          • Phone Number: 973-971-5900
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Sanford South University Medical Center
        • Principal Investigator:
          • Preston D. Steen
        • Contact:
          • Site Public Contact
          • Phone Number: 701-234-6161
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Southpointe-Sanford Medical Center Fargo
        • Principal Investigator:
          • Preston D. Steen
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Sanford Medical Center Fargo
        • Principal Investigator:
          • Preston D. Steen
        • Contact:
          • Site Public Contact
          • Phone Number: 800-437-4010
      • Jamestown, North Dakota, United States, 58401
        • Recruiting
        • Essentia Health - Jamestown Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45247
      • Cincinnati, Ohio, United States, 45255
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC-Presbyterian Hospital
        • Principal Investigator:
          • Robert E. Schoen
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-2811
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H Johnson VA Medical Center
        • Contact:
        • Principal Investigator:
          • Oleksandra Lupak
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Greenville Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Texas
      • Bryan, Texas, United States, 77802
    • Washington
      • Bremerton, Washington, United States, 98310
      • Burien, Washington, United States, 98166
      • Enumclaw, Washington, United States, 98022
      • Federal Way, Washington, United States, 98003
      • Lakewood, Washington, United States, 98499
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Appleton, Wisconsin, United States, 54915
        • Recruiting
        • Ascension Saint Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Northwest Wisconsin Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Brookfield, Wisconsin, United States, 53045
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Chilton, Wisconsin, United States, 53014
        • Recruiting
        • Ascension Calumet Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Eau Claire, Wisconsin, United States, 54701
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Ascension Saint Francis - Reiman Cancer Center
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Franklin
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Hayward, Wisconsin, United States, 54843
        • Recruiting
        • Essentia Health-Hayward Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Marshfield, Wisconsin, United States, 54449
      • Mequon, Wisconsin, United States, 53097
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital Ozaukee
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Milwaukee, Wisconsin, United States, 53210
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Ascension Saint Francis Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Ascension Mercy Hospital
        • Principal Investigator:
          • Shannon Offerman
        • Contact:
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • Ascension All Saints Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Rice Lake, Wisconsin, United States, 54868
      • Spooner, Wisconsin, United States, 54801
        • Recruiting
        • Essentia Health-Spooner Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Stevens Point, Wisconsin, United States, 54482
      • Superior, Wisconsin, United States, 54880
        • Recruiting
        • Essentia Health Saint Mary's Hospital - Superior
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 701-364-6272
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.

    • 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 greater 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
5-Year and 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy
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.
Experimental: Arm 2
10-Year Surveillance Colonoscopy after Qualifying Colonoscopy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of colorectal cancer
Time Frame: 10 years
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.
10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of advanced adenoma
Time Frame: 10 years
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.
10 years
Colorectal cancer mortality
Time Frame: 10 years
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.
10 years
Incidence of stage III-IV colorectal cancer
Time Frame: 10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Robert Schoen, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Estimated)

November 1, 2035

Study Completion (Estimated)

November 1, 2065

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-CC005
  • NCI-2020-00733 (Registry Identifier: CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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