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

(FORTE Trial)

Recruiting in Palo Alto (17 mi)

+435 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NRG Oncology

Disqualifiers: Colorectal cancer, Inflammatory bowel disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to determine the best schedule for preventing small, non-dangerous growths in the colon from turning into cancer by regularly checking and removing them.

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 data supports the effectiveness of the treatment 5-year and 10-Year Surveillance Colonoscopy for colorectal cancer prevention?

The research suggests that a 10-year colonoscopy after a negative result does not significantly reduce early colorectal cancer risk, indicating the need for further studies. However, surveillance colonoscopy is generally aimed at reducing cancer incidence by removing growths and detecting cancer early, especially in those with higher risk factors. ^{1 2 3 4 5}

Is colonoscopy generally safe for humans?

Colonoscopy is generally considered safe, but like any medical procedure, it can have risks. Some studies have looked at adverse events (unwanted side effects) during long-term colonoscopy programs, but detailed safety data is limited. ^{1 2 5 6 7}

How does the 5-year vs. 10-year colonoscopy treatment for colorectal cancer prevention differ from other treatments?

This treatment is unique because it compares the effectiveness of having a colonoscopy every 5 years versus every 10 years for preventing colorectal cancer, focusing on the timing of surveillance rather than a new drug or procedure. ^{1 2 3 4 7}

Research Team

Robert Schoen, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy (Procedure)

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.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

Group II: Arm 1 Experimental Treatment 1 Intervention

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:

🇺🇸 Approved in United States as Surveillance Colonoscopy for:

• Colorectal Cancer Screening
• Follow-up after adenomatous polyp removal

🇪🇺 Approved in European Union as Surveillance Colonoscopy for:

• Colorectal Cancer Screening
• Follow-up after adenomatous polyp removal

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Abbott-Northwestern Hospital Minneapolis, MN

Southpointe-Sanford Medical Center Fargo Fargo, ND

Essentia Health - Deer River Clinic Deer River, MN

Spectrum Health Reed City Hospital Reed City, MI

More Trial Locations

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Patients Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Risk of colorectal cancer after a negative colonoscopy in low-to-moderate risk individuals: impact of a 10-year colonoscopy. [2018] Background and study aims National societies recommend colorectal cancer (CRC) screening 10 years after a normal ("negative") colonoscopy in low-risk individuals. We studied the impact of a 10-year repeat colonoscopy on the risk of early incident CRC. Patients and methods We used health administrative data from Ontario, Canada, to conduct a population-based retrospective cohort study in 50 - 74-year-old individuals at low-to-moderate risk of CRC who had a negative colonoscopy between 1996 and 2001. We approximated exposure to repeat colonoscopy using an 8 - 12-year window. We excluded individuals who underwent lower endoscopy or colectomy, developed CRC, or were lost to follow-up between the baseline and repeat colonoscopies. We matched exposed individuals 1:1 to individuals who did not undergo lower endoscopy within 12 years for age, sex, and calendar year of baseline colonoscopy, and followed matched pairs for incident CRC. The primary analysis was multivariable hazards regression, adjusting for competing risks. Results A total of 13 350 matched pairs were observed for a median of 4.5 years (interquartile range 3.2 - 5.9 years). The cumulative probability of CRC following the matching date was 0.70 % (95 % confidence interval [CI] 0.42 % - 1.11 %) in individuals who underwent repeat colonoscopy and 0.77 % (95 %CI 0.48 % - 1.2 %) in individuals who did not undergo repeat colonoscopy. The adjusted hazard ratio for CRC was 0.91 (95 %CI 0.68 - 1.22). Conclusions We did not find an association between a second colonoscopy performed 10 years after a negative colonoscopy and early incident CRC. Our findings support the need for further studies on the utility of 10-year re-screening with colonoscopy in this setting.

2. United States pubmed.ncbi.nlm.nih.gov

Five-year colon surveillance after screening colonoscopy. [2022] Outcomes of colon surveillance after colorectal cancer screening with colonoscopy are uncertain. We conducted a prospective study to measure incidence of advanced neoplasia in patients within 5.5 years of screening colonoscopy.

3. United States pubmed.ncbi.nlm.nih.gov

Colonoscopy surveillance after polypectomy may be extended beyond five years. [2022] Colonoscopy surveillance interval data longer than 5 years are limited. We examined adenoma yield to identify factors that predict appropriate intervals for postpolypectomy surveillance greater than 5 years, including risk of advanced adenoma recurrence.

4. United States pubmed.ncbi.nlm.nih.gov

Baseline Colonoscopy Findings Associated With 10-Year Outcomes in a Screening Cohort Undergoing Colonoscopy Surveillance. [2020] Few studies have evaluated long-term outcomes of ongoing colonoscopic screening and surveillance in a screening population. We aimed to determine the 10-year risk for advanced neoplasia (defined as adenomas ≥10mm, adenomas with villous histology or high-grade dysplasia, or colorectal cancer [CRC]) and assessed whether baseline colonoscopy findings were associated with long-term outcomes.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Surveillance after colorectal polyp removal. [2022] Surveillance colonoscopy is aimed to reduce CRC incidence and mortality by removing adenomas and detecting CRC in early stage. However, colonoscopy is an invasive and expensive procedure and surveillance colonoscopy should be targeted at those who are most likely to benefit at the minimum frequency required to protect for cancer. Surveillance recommendations are based on guidelines, but the recommendations in those guidelines are based on moderate to low quality evidence and adherence to these guidelines is poor. As surveillance colonoscopy is one of the main indications for colonoscopy and surveillance colonoscopies are filling colonoscopy lists, the current surveillance practice results in spending lots of money and capacity in a suboptimal way. Randomized controlled trials to compare surveillance intervals are not available. However, current evidence based on several case-control and cohort studies suggests there is no need for surveillance in patients with low-risk adenomas, i.e. 1-2 adenomas smaller than 10 mm. Patients with 3 or more adenomas or any adenoma larger than 10 mm seem to be the ones at real risk for metachronous adenomas or cancer. In those patients, surveillance colonoscopy is indicated at 3 years after baseline until ongoing studies will confirm the safety of enlarging this interval. Randomized controlled trials and experimental research are important in order to provide the necessary scientific evidence for the optimization of follow-up strategies for patients with adenomas and serrated polyps.

6. United States pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort. [2023] Data are limited regarding colonoscopy risk during long-term, programmatic colorectal cancer screening and follow-up. We aimed to describe adverse events during follow-up in a colonoscopy screening program after the baseline examination and examine factors associated with increased risk.

7. Australia pubmed.ncbi.nlm.nih.gov

Outcomes after 10 years of a community-based flexible sigmoidoscopy screening program for colorectal carcinoma. [2021] To evaluate the outcomes 10 years after a flexible sigmoidoscopy colorectal cancer (CRC) screening program in asymptomatic average-risk individuals.