NCT05080673 · NRG Oncology
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
(FORTE)
What this study is about
This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomly assigned to surveillance colonoscopy at 10 years compared to participants randomly assigned to surveillance colonoscopy at 5 and 10 years.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Fairbanks, Alaska
- Goodyear, Arizona
- Kingman, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Fort Smith, Arkansas
- Hot Springs, Arkansas
- Little Rock, Arkansas
- Anaheim, California
- Arroyo Grande, California
- Baldwin Park, California
- Bellflower, California
And 311 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations