RECRUITING

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

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Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the Rectum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-09
Study Completion:2065-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05080673

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.

Ages Eligible for Study:50 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
  2. * 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.
  3. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.
  4. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.
  5. * Complete excision of all observed polyps in qualifying colonoscopy
  6. * Participants must be able to read or understand English or Spanish.
  1. * • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy.
  2. * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.
  3. * Traditional serrated adenomas found on the qualifying colonoscopy.
  4. * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.
  5. * 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.
  6. * Colonoscopy performed after the qualifying colonoscopy but prior to randomization.
  7. * Incomplete qualifying colonoscopy (e.g., cecum not visualized).
  8. * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)
  9. * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)
  10. * 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.
  11. * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]).
  12. * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer.
  13. * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).
  14. * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.
  15. * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.

Contacts and Locations

Study Contact

Director, Department of Regulatory Affairs
CONTACT
412-339-5300
langerj@nrgoncology.org
Norman Wolmark, MD
CONTACT

Principal Investigator

Robert Schoen, MD
STUDY_CHAIR
University of Pittsburgh

Study Locations (Sites)

Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
United States
Epic Care-Dublin
Dublin, California, 94568
United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608
United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
United States
Bay Area Tumor Institute
Oakland, California, 94609
United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589
United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597
United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
United States
Porter Adventist Hospital
Denver, Colorado, 80210
United States
Mercy Medical Center
Durango, Colorado, 81301
United States
Southwest Oncology PC
Durango, Colorado, 81301
United States
Saint Anthony Hospital
Lakewood, Colorado, 80228
United States
Littleton Adventist Hospital
Littleton, Colorado, 80122
United States
Longmont United Hospital
Longmont, Colorado, 80501
United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501
United States
Parker Adventist Hospital
Parker, Colorado, 80138
United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
United States
Rush - Copley Medical Center
Aurora, Illinois, 60504
United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Carle on Vermilion
Danville, Illinois, 61832
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
The Carle Foundation Hospital
Urbana, Illinois, 61801
United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
United States
Greater Regional Medical Center
Creston, Iowa, 50801
United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509
United States
Saint Joseph London
London, Kentucky, 40741
United States
Jewish Hospital
Louisville, Kentucky, 40202
United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215
United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165
United States
Bronson Battle Creek
Battle Creek, Michigan, 49017
United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
United States
Borgess Medical Center
Kalamazoo, Michigan, 49048
United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444
United States
Lakeland Hospital Niles
Niles, Michigan, 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085
United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Metro Health Hospital
Wyoming, Michigan, 49519
United States
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Cambridge Medical Center
Cambridge, Minnesota, 55008
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805
United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537
United States
Essentia Health - Fosston
Fosston, Minnesota, 56542
United States
Unity Hospital
Fridley, Minnesota, 55432
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Health Partners Inc
Minneapolis, Minnesota, 55454
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
New Ulm Medical Center
New Ulm, Minnesota, 56073
United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072
United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
United States
Ridgeview Medical Center
Waconia, Minnesota, 55387
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187
United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803
United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847
United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
United States
Creighton University Medical Center
Omaha, Nebraska, 68131
United States
Midlands Community Hospital
Papillion, Nebraska, 68046
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
United States
Sanford South University Medical Center
Fargo, North Dakota, 58103
United States
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
United States
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
United States
Bethesda North Hospital
Cincinnati, Ohio, 45242
United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
United States
Harrison Medical Center
Bremerton, Washington, 98310
United States
Highline Medical Center-Main Campus
Burien, Washington, 98166
United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
United States
Saint Francis Hospital
Federal Way, Washington, 98003
United States
Saint Clare Hospital
Lakewood, Washington, 98499
United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405
United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
United States
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132
United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097
United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, 53210
United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211
United States
Ascension Saint Francis Hospital
Milwaukee, Wisconsin, 53215
United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482
United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Robert Schoen, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2022-02-09
Study Completion Date2065-11-01

Study Record Updates

Study Start Date2022-02-09
Study Completion Date2065-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum