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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.
Must not have
Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)
Family history of CRC diagnosed at greater 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Summary

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.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to remove part or all of my colon.
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A close family member had colorectal cancer at 60 or older, or two relatives had it at any age.
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I have had a large growth in my colon before.
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I have a family history of significant colorectal cancer risk (FAP or Lynch Syndrome).
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I have an inflammatory bowel condition like Crohn's or ulcerative colitis.
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My last colonoscopy showed I have traditional serrated adenomas.
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I have a small growth in my colon that is 1 cm or smaller.
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I have a genetic mutation linked to a high risk of colorectal cancer.
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I have had colorectal cancer or polyps before, but not found in my last colonoscopy.

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

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Rectal Adenocarcinoma include surgery, chemotherapy, and radiotherapy. Surgery physically removes the tumor, which is essential for localized disease. Chemotherapy, using drugs like fluorouracil and oxaliplatin, targets rapidly dividing cancer cells to reduce tumor size and prevent metastasis. Radiotherapy employs high-energy radiation to damage the DNA of cancer cells, leading to their death and tumor shrinkage. These treatments are crucial for rectal adenocarcinoma patients as they address both local and systemic disease, improving survival rates and reducing recurrence. Surveillance colonoscopy is important for early detection and monitoring, ensuring timely intervention if cancer recurs.

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
237 Previous Clinical Trials
93,274 Total Patients Enrolled
1 Trials studying Rectal Adenocarcinoma
363 Patients Enrolled for Rectal Adenocarcinoma
National Cancer Institute (NCI)NIH
13,878 Previous Clinical Trials
41,003,554 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
~6333 spots leftby Nov 2035