5-Year vs. 10-Year Colonoscopy for Colorectal Cancer Prevention
(FORTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how often individuals with 1 to 2 small, non-advanced adenomas (polyps that can become cancerous) should undergo a colonoscopy to prevent colorectal cancer. Participants will be randomly assigned to have their next colonoscopy either in 5 years and then again in 10 years, or just in 10 years. The study aims to determine if cancer rates differ between these two groups. Individuals who recently had a colonoscopy revealing 1-2 small polyps and have no history of colorectal cancer may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to research that could enhance future colorectal cancer prevention strategies.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.
What prior data suggests that this colonoscopy protocol is safe for colorectal cancer prevention?
Research has shown that colonoscopies, whether performed every 5 or 10 years, are generally safe for most people. For the 5-year check-up, studies have found it effective in preventing colorectal cancer. Specifically, one study found a very low risk of developing colorectal cancer five years after a negative colonoscopy, demonstrating the procedure's effectiveness and manageability over time.
For the 10-year check-up, studies have also shown positive outcomes. Research involving over a million people found a low chance of developing colorectal cancer over 10 years, highlighting the procedure's safety and effectiveness. Another study reported a very low risk of dying from colorectal cancer after 10 years.
Both 5-year and 10-year colonoscopies are common and have a strong safety record. Serious side effects are rare, making these procedures generally safe options for cancer prevention.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it could redefine how often people need colonoscopies for colorectal cancer prevention. Currently, the standard recommendation is a colonoscopy every 10 years after a normal result, but this trial is comparing the effectiveness of 5-year versus 10-year surveillance schedules. The trial could show that more frequent screenings help catch potential issues earlier, potentially leading to better outcomes. Alternatively, it might confirm that 10-year intervals are adequate, which would mean fewer procedures for patients while still maintaining safety. This research is crucial as it may lead to more personalized and effective screening strategies.
What evidence suggests that this trial's surveillance colonoscopy schedules could be effective for colorectal cancer prevention?
This trial will compare the effectiveness of 5-year versus 10-year surveillance colonoscopy schedules in preventing colorectal cancer (CRC). Studies have shown that colonoscopies every 5 or 10 years can effectively reduce the risk of developing CRC. Research indicates that both schedules can prevent about 30% of CRC cases. These screenings catch cancer early, which is crucial for reducing deaths from CRC. Both methods have proven effective in lowering cancer rates and detecting cancer before it becomes more serious.23467
Who Is on the Research Team?
Robert Schoen, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for people who've had a colonoscopy within the last 4 years, found to have 1-2 small non-advanced adenomas, and removed them completely. They must be able to understand English or Spanish and give informed consent. It's not for those with high genetic risk of colorectal cancer, inflammatory bowel disease, large hyperplastic polyps, previous significant cancers (except certain skin cancers), or life expectancy less than 10 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Qualifying Colonoscopy
Participants undergo a qualifying colonoscopy to identify 1-2 non-advanced adenomas
Surveillance Colonoscopy
Participants are randomized to undergo surveillance colonoscopy at either 5 years and 10 years or only at 10 years
Follow-up
Participants are monitored for incidence of advanced adenoma and colorectal cancer
What Are the Treatments Tested in This Trial?
Interventions
- 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy is already approved in United States, European Union for the following indications:
- Colorectal Cancer Screening
- Follow-up after adenomatous polyp removal
- Colorectal Cancer Screening
- Follow-up after adenomatous polyp removal
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator