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5-Year vs. 10-Year Colonoscopy for Colorectal Cancer Prevention (FORTE Trial)

N/A
Recruiting
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complete excision of all observed polyps in qualifying colonoscopy
Participants must be able to read or understand English or Spanish.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

FORTE Trial Summary

This trial is testing whether colonoscopies every 10 years are as effective as every 5 years in preventing colorectal cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Colonoscopy side effects can include discomfort, bloating, cramps during the procedure; rare risks involve bleeding or tearing in the colon wall.

FORTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
All polyps found during my colonoscopy were completely removed.
Select...
I can read or understand English or Spanish.

FORTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of colorectal cancer
Other outcome measures
Colorectal cancer mortality
Incidence of advanced adenoma
Incidence of stage III-IV colorectal cancer

FORTE Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
10-Year Surveillance Colonoscopy after Qualifying Colonoscopy
Group II: Arm 1Experimental Treatment1 Intervention
5-Year and 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
91,352 Total Patients Enrolled
1 Trials studying Rectal Adenocarcinoma
363 Patients Enrolled for Rectal Adenocarcinoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,915,021 Total Patients Enrolled
15 Trials studying Rectal Adenocarcinoma
1,152 Patients Enrolled for Rectal Adenocarcinoma
Robert Schoen, MDStudy ChairUniversity of Pittsburgh
1 Previous Clinical Trials
137 Total Patients Enrolled

Media Library

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy Clinical Trial Eligibility Overview. Trial Name: NCT05080673 — N/A
Rectal Adenocarcinoma Research Study Groups: Arm 2, Arm 1
Rectal Adenocarcinoma Clinical Trial 2023: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy Highlights & Side Effects. Trial Name: NCT05080673 — N/A
5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05080673 — N/A
Rectal Adenocarcinoma Patient Testimony for trial: Trial Name: NCT05080673 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can be considered a viable candidate for this trial?

"This study is currently searching for 95 hundred individuals, aged 50 to 70 years old, who possess adenocarcinoma. To meet the inclusion criteria, participants must have a first-time diagnosis of 1 or 2 non-advanced tubular adenomas within 4 years prior to randomization; sessile serrated polyps/adenomas (provided they do not fit advanced adenoma standards); undergone an extensive and thorough colonoscopy that reached their cecum with sufficient cleansing in the same time frame; underwent complete excision of all seen polyps from the qualifying colonoscopy; can read and understand English or"

Answered by AI

Are there current openings for enrollment in this research?

"According to the listing on clinicaltrials.gov, this research project is still in its recruitment phase. The first posting was made on October 6th 2021 with subsequent changes noted as recent as March 30th 2022."

Answered by AI

How many medical centers are operating this research project?

"At present, this clinical trial is operating in 100 cities across the nation. These include Arroyo Grande, Saint Paul and Sandstone as well as other locales. Patients are advised to consider enrolling at a site nearest them to avoid extensive travel requirements."

Answered by AI

Does this research project accept individuals younger than 85 years of age?

"This clinical trial is recruiting patients aged between 50 and 70 years old. There are 7 trials for minors, as well as 773 studies for seniors over the age of 65."

Answered by AI

How many individuals are receiving treatment as part of the current clinical trial?

"To complete this trial, 9500 eligible patients are necessary. In particular, individuals can join the medical study at Mission Hope Medical Oncology - Arroyo Grande in California or Regions Hospital of Minnesota."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Hennepin County Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was going through the trials I might fir for.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
2021. "Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05080673.
All > Colorectal Cancer Glendale
~6333 spots leftby Nov 2035
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