Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Purpose
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.
Conditions
- Adenocarcinoma of the Colon
- Adenocarcinoma of the Rectum
Eligibility
- Eligible Ages
- Between 45 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Surveillance
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 |
5-Year and 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy |
|
|
Experimental Arm 2 |
10-Year Surveillance Colonoscopy after Qualifying Colonoscopy |
|
Recruiting Locations
Goodyear, Arizona 85338
Site Public Contact
623-207-3000
Kingman, Arizona 86401
Phoenix, Arizona 85004
Tucson, Arizona 85719
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Little Rock, Arkansas 72205
Anaheim, California 92806
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Baldwin Park, California 91706
Bellflower, California 90706
Carmichael, California 95608
Carmichael, California 95608
Elk Grove, California 95758
Fontana, California 92335
Harbor City, California 90710
Irvine, California 92618
Los Angeles, California 90027
Los Angeles, California 90034
Los Angeles, California 90095
Site Public Contact
888-798-0719
Martinez, California 94553-3156
Site Public Contact
925-957-5400
Merced, California 95340
Ontario, California 91761
Palo Alto, California 94304
Panorama City, California 91402
Riverside, California 92505
Rocklin, California 95765
Sacramento, California 95816
San Diego, California 92108
San Diego, California 92120
San Luis Obispo, California 93401
San Marcos, California 92078
Santa Maria, California 93444
Stockton, California 95204
Site Public Contact
209-461-5257
Vallejo, California 94589
Walnut Creek, California 94598
Woodland, California 95695
Woodland Hills, California 91367
Aurora, Colorado 80012
Aurora, Colorado 80045
Site Public Contact
888-336-8262
Aurora, Colorado 80045
Site Public Contact
720-848-0650
Boulder, Colorado 80303
Boulder, Colorado 80304
Centennial, Colorado 80112
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Denver, Colorado 80205
Denver, Colorado 80209
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80220
Durango, Colorado 81301
Durango, Colorado 81301
Englewood, Colorado 80113
Englewood, Colorado 80113
Lafayette, Colorado 80026
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Littleton, Colorado 80120
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Longmont, Colorado 80501
Longmont, Colorado 80501
Pueblo, Colorado 81004
Thornton, Colorado 80260
Westminster, Colorado 80023
New Haven, Connecticut 06520
West Haven, Connecticut 06516
Site Public Contact
203-937-3421
Washington D.C., District of Columbia 20002
Washington D.C., District of Columbia 20007
Site Public Contact
202-444-2223
Washington D.C., District of Columbia 20037
Site Public Contact
202-741-2210
Aventura, Florida 33180
Bay Pines, Florida 33744
Gainesville, Florida 32610
Miami, Florida 33136
Site Public Contact
305-243-2647
Miami, Florida 33176
Miami Beach, Florida 33140
Augusta, Georgia 30912
Savannah, Georgia 31404
Savannah, Georgia 31404
Coeur d'Alene, Idaho 83814
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Alton, Illinois 62002
Site Public Contact
618-463-5623
Chicago, Illinois 60611
Chicago, Illinois 60612
Site Public Contact
312-864-5204
Maywood, Illinois 60153
Site Public Contact
708-226-4357
Mount Vernon, Illinois 62864
Rockford, Illinois 61114
Zion, Illinois 60099
Site Public Contact
844-793-0745
Crown Point, Indiana 46307
Site Public Contact
219-310-2550
Dyer, Indiana 46311
Site Public Contact
219-924-8178
Hobart, Indiana 46342
Site Public Contact
219-947-1795
Hobart, Indiana 46342
Indianapolis, Indiana 46312
Munster, Indiana 46321
Site Public Contact
219-836-3349
Munster, Indiana 46321
Valparaiso, Indiana 46383
Fairway, Kansas 66205
Garden City, Kansas 67846
Great Bend, Kansas 67530
Kansas City, Kansas 66160
Overland Park, Kansas 66211
Parsons, Kansas 67357
Site Public Contact
620-421-4881
Pittsburg, Kansas 66762
Site Public Contact
888-446-3729
Topeka, Kansas 66606
Site Public Contact
785-270-4939
Westwood, Kansas 66205
Wichita, Kansas 67218
Site Public Contact
316-685-2221
Bardstown, Kentucky 40004
Corbin, Kentucky 40701
Edgewood, Kentucky 41017
Fort Thomas, Kentucky 41075
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Lexington, Kentucky 40509
London, Kentucky 40741
Mount Sterling, Kentucky 40353
Paducah, Kentucky 42003
Shreveport, Louisiana 71103
Scarborough, Maine 04074
Baltimore, Maryland 21244
Gaithersburg, Maryland 20879
Kensington, Maryland 20895
Largo, Maryland 20774
Lutherville, Maryland 21093
Boston, Massachusetts 02114
Site Public Contact
877-726-5130
Jamaica Plain, Massachusetts 02130
Battle Creek, Michigan 49017
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
Site Public Contact
574-647-7370
Kalamazoo, Michigan 49048
Site Public Contact
574-647-7370
Muskegon, Michigan 49444
Niles, Michigan 49120
Site Public Contact
616-391-1230
Norton Shores, Michigan 49444
Reed City, Michigan 49677
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Traverse City, Michigan 49684
Wyoming, Michigan 49519
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
Site Public Contact
218-828-2880
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Crosslake, Minnesota 56442
Site Public Contact
218-692-1010
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Ely, Minnesota 55731
Site Public Contact
218-365-7900
Fosston, Minnesota 56542
Hibbing, Minnesota 55746
Site Public Contact
218-786-3308
International Falls, Minnesota 56649
Site Public Contact
218-283-9431
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55417
Site Public Contact
612-467-2800
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
Moose Lake, Minnesota 55767
Site Public Contact
218-485-4481
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Pequot Lakes, Minnesota 56472
Site Public Contact
218-568-4416
Pine River, Minnesota 56474
Site Public Contact
218-587-4416
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Rochester, Minnesota 55905
Site Public Contact
855-776-0015
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Staples, Minnesota 56479
Site Public Contact
218-894-7870
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
Site Public Contact
605-312-3320
Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Ballwin, Missouri 63011
Site Public Contact
888-446-3729
Bolivar, Missouri 65613
Branson, Missouri 65616
Site Public Contact
417-269-4520
Cape Girardeau, Missouri 63703
Site Public Contact
888-446-3729
Joplin, Missouri 64804
Joplin, Missouri 64804
Kansas City, Missouri 64128
Site Public Contact
800-525-1483
Osage Beach, Missouri 65065
Rolla, Missouri 65401
Site Public Contact
573-458-6379
Rolla, Missouri 65401
Saint Joseph, Missouri 64506
Springfield, Missouri 65804
Site Public Contact
417-269-4520
Springfield, Missouri 65807
Site Public Contact
417-269-4520
St Louis, Missouri 63109
Site Public Contact
888-446-3729
St Louis, Missouri 63128
St Louis, Missouri 63141
Site Public Contact
314-251-7066
Washington, Missouri 63090
Site Public Contact
636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Havre, Montana 59501
Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59804
Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Omaha, Nebraska 68131
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas, Nevada 89103
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Site Public Contact
702-851-4672
Las Vegas, Nevada 89109
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Morristown, New Jersey 07960
Site Public Contact
973-971-5900
Albuquerque, New Mexico 87106
New York, New York 10016
New York, New York 10032
Clinton, North Carolina 28328
Goldsboro, North Carolina 27534
Jacksonville, North Carolina 28546
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Site Public Contact
701-234-6161
Fargo, North Dakota 58103
Site Public Contact
605-312-3320
Fargo, North Dakota 58104
Site Public Contact
800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Beachwood, Ohio 44122
Centerville, Ohio 45459
Cincinnati, Ohio 45220
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Columbus, Ohio 43210
Dayton, Ohio 45409
Dayton, Ohio 45409
Site Public Contact
937-276-8320
Dayton, Ohio 45415
Franklin, Ohio 45005-1066
Greenville, Ohio 45331
Site Public Contact
937-569-7515
Troy, Ohio 45373
Westlake, Ohio 44145
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Portland, Oregon 97239
Portland, Oregon 97239
Site Public Contact
800-949-1004
Danville, Pennsylvania 17822
Hazleton, Pennsylvania 18201
Lewisburg, Pennsylvania 17837
Pittsburgh, Pennsylvania 15213
Site Public Contact
412-647-2811
Pottsville, Pennsylvania 17901
Scranton, Pennsylvania 18510
Wilkes-Barre, Pennsylvania 18711
Providence, Rhode Island 02908
Site Public Contact
866-590-2976
Charleston, South Carolina 29401
Gaffney, South Carolina 29341
Greenville, South Carolina 29605
Greer, South Carolina 29651
Spartanburg, South Carolina 29303
Site Public Contact
864-560-6812
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29307
Site Public Contact
864-560-6812
Union, South Carolina 29379
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Memphis, Tennessee 38120
Dallas, Texas 75390
San Antonio, Texas 78229
Site Public Contact
877-469-5300
Salt Lake City, Utah 84148
Site Public Contact
801-582-1565
Burke, Virginia 22015
McLean, Virginia 22102
Richmond, Virginia 23235
Richmond, Virginia 23298
Roanoke, Virginia 24033
Site Public Contact
540-981-7377
Woodbridge, Virginia 22192
Port Townsend, Washington 98368
Site Public Contact
360-344-3091
Renton, Washington 98055
Silverdale, Washington 98383
Yakima, Washington 98902
Bridgeport, West Virginia 26330
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Princeton, West Virginia 24740
Site Public Contact
304-487-7515
Wheeling, West Virginia 26003
Site Public Contact
304-243-6442
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Eau Claire, Wisconsin 54701
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
Site Public Contact
218-568-4416
Janesville, Wisconsin 53548
Madison, Wisconsin 53705
Site Public Contact
608-256-1901
Marshfield, Wisconsin 54449
Milwaukee, Wisconsin 53295
Site Public Contact
888-469-6614
Minocqua, Wisconsin 54548
New Richmond, Wisconsin 54017
Rice Lake, Wisconsin 54868
Spooner, Wisconsin 54801
Stevens Point, Wisconsin 54482
Superior, Wisconsin 54880
Site Public Contact
701-364-6272
Wausau, Wisconsin 54401
Weston, Wisconsin 54476
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Bayamón, Puerto Rico 00959-5060
Site Public Contact
787-395-7085
Bayamón, Puerto Rico 00961
Site Public Contact
787-780-2865
Dorado, Puerto Rico 00646
Manatí, Puerto Rico 00674
Site Public Contact
787-621-4397
San Juan, Puerto Rico 00902
San Juan, Puerto Rico 00909
San Juan, Puerto Rico 00917
Site Public Contact
787-274-3387
San Juan, Puerto Rico 00921-3201
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
Site Public Contact
787-763-1296
More Details
- Status
- Recruiting
- Sponsor
- NRG Oncology
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.