9500 Participants Needed

5-Year vs. 10-Year Colonoscopy for Colorectal Cancer Prevention

(FORTE Trial)

Recruiting at 466 trial locations
NW
DD
Overseen ByDirector, Department of Regulatory Affairs
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NRG Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

RS

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

All polyps found during my colonoscopy were completely removed.
I had a thorough colonoscopy with clear views and good cleansing within the last 4 years.
I was diagnosed with 1-2 small, non-advanced tubular adenomas less than 4 years ago.
See 3 more

Exclusion Criteria

I have had surgery to remove part or all of my colon.
A close family member had colorectal cancer at 60 or older, or two relatives had it at any age.
I have had a large growth in my colon before.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualifying Colonoscopy

Participants undergo a qualifying colonoscopy to identify 1-2 non-advanced adenomas

1 day
1 visit (in-person)

Surveillance Colonoscopy

Participants are randomized to undergo surveillance colonoscopy at either 5 years and 10 years or only at 10 years

10 years
2 visits (in-person) for 5-year and 10-year group, 1 visit (in-person) for 10-year group

Follow-up

Participants are monitored for incidence of advanced adenoma and colorectal cancer

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
Trial Overview The study is testing if it's just as effective to do follow-up colonoscopies at ten-year intervals instead of five after finding and removing small benign polyps. Participants are randomly placed into two groups: one will have a check-up at five years and another only at ten years.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Group II: Arm 1Experimental Treatment1 Intervention

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Surveillance Colonoscopy for:
🇪🇺
Approved in European Union as Surveillance Colonoscopy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials
242
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 13,350 matched pairs of individuals aged 50-74 with a previous negative colonoscopy, undergoing a repeat colonoscopy 10 years later did not significantly reduce the risk of early incident colorectal cancer (CRC).
The cumulative probability of developing CRC was similar between those who had a repeat colonoscopy (0.70%) and those who did not (0.77%), suggesting that the current recommendation for 10-year re-screening may need further evaluation.
Risk of colorectal cancer after a negative colonoscopy in low-to-moderate risk individuals: impact of a 10-year colonoscopy.Murthy, SK., Dubé, C., Rostom, A., et al.[2018]
In a study of 3121 asymptomatic veterans followed for 10 years, those with baseline colorectal cancer had the highest 10-year risk of advanced neoplasia at 43.7%, while those with 1-2 small adenomas had a much lower risk of 6.3%.
The findings suggest that individuals with only 1 or 2 small adenomas at baseline have a low risk of developing advanced neoplasia over 10 years, indicating that alternative surveillance strategies could be considered for these patients.
Baseline Colonoscopy Findings Associated With 10-Year Outcomes in a Screening Cohort Undergoing Colonoscopy Surveillance.Lieberman, D., Sullivan, BA., Hauser, ER., et al.[2020]
In a study of 3,121 asymptomatic subjects aged 50 to 75, those with baseline neoplasia had a significantly higher risk of developing advanced neoplasia within 5.5 years, with relative risks ranging from 1.92 to 6.87 depending on the type and size of adenomas found during initial screening.
Patients with 1 or 2 tubular adenomas smaller than 10 mm were identified as a low-risk group for developing serious lesions, suggesting that not all neoplasia findings carry the same risk for future complications.
Five-year colon surveillance after screening colonoscopy.Lieberman, DA., Weiss, DG., Harford, WV., et al.[2022]

Citations

Colorectal Cancer After Screening Colonoscopy: 10-Year ...RESULTS: Overall, 1,095,381 persons were included. The 10-year cumulative CRC incidence was 1.5% in cohort 1 and 0.6% in cohort 2. The ...
Effect of Colonoscopy Screening on Risks of Colorectal ...In this randomized trial, the risk of colorectal cancer at 10 years was lower among participants who were invited to undergo screening colonoscopy.
Contribution of Surveillance Colonoscopy to Colorectal ...We estimated that surveillance colonoscopy during 10 years of follow up (in the PLCO colonoscopy cohort) prevented 30% of CRC cases.
Prevalence of Colorectal Neoplasia 10 or More Years After ...This cross-sectional study examines the prevalence of advanced colorectal neoplasms at least 10 years after a negative screening colonoscopy ...
Contributions of early detection and cancer prevention to ...Screening colonoscopy, recommended every 10 years, reduces mortality from colorectal cancer (CRC) by early detection of prevalent but undiagnosed CRC.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31376388/
Baseline Colonoscopy Findings Associated With 10-Year ...The cumulative 10-year incidence of advanced neoplasia was highest among those with baseline CRC (43.7%; 95% CI 13.0%-74.4%), followed by those with baseline ...
Colorectal cancer incidence after the first surveillance ...This study examined CRC incidence over a median of 8 years after SC1 among 10 508 patients grouped by polyp findings at baseline and SC1, with 6587 (63%) in the ...
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