What side effects are associated with this type of intervention?

The most common treatments for colorectal cancer, particularly those involving colonoscopy and the removal of colorectal adenomas, can have several side effects. Colonoscopy itself is generally safe but can occasionally lead to complications such as perforation, bleeding, and infection. Post-procedural discomfort, bloating, and cramping are also common. Surgical treatments, such as abdominoperineal resection (APR), can result in poor anorectal function, leading to increased stool frequency, incontinence, and perianal irritation, which can significantly impact quality of life. Chemopreventive treatments, like the use of aspirin, may cause gastrointestinal issues, including ulcers and bleeding. Overall, while these treatments are effective, they come with a range of potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapeutic agents such as fluorouracil (5-FU) and oxaliplatin, which are often used in combination for adjuvant therapy in stage III colon cancer. Additionally, targeted therapies like cetuximab and bevacizumab have been approved for metastatic colorectal cancer. These treatments aim to reduce tumor size and prevent recurrence, complementing procedures like colonoscopy that allow for the direct visualization and removal of colorectal adenomas.

What other types of research exist?

Promising, novel alternatives to colonoscopy for colorectal cancer patients in 2024 include: 1) Virtual colonoscopy, which is a non-invasive imaging technique that has shown accuracy in detecting colorectal cancers and polyps. 2) Fecal immunochemical tests (FIT), which are non-invasive, cost-effective, and supported by high-quality evidence for reducing colorectal cancer mortality. 3) New colonoscopic technologies such as full-spectrum endoscopy and balloon colonoscopes, which have demonstrated higher polyp detection rates and improved patient satisfaction in preliminary studies.

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Colonoscopy vs FIT Screening for Colorectal Cancer (CONFIRM Trial)

N/A

Waitlist Available

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female adults aged 50-75 years of age

Be older than 18 years old

Must not have

Prior history of colonic disease including: inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease), one or more colorectal neoplastic polyps (i.e. adenomas), colorectal cancer, prior history of colonic resection

Prior colonic examination, including: colonoscopy within the past 9.5 years, sigmoidoscopy within the past 5 years, barium enema within the past 5 years, CT colonography within the past 5 years, gFOBT or FIT in the past 10 months, stool DNA test within the past 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods for colorectal cancer screening in people aged 50-75. One method uses a camera to find and remove precancerous growths, while the other checks for hidden blood in stool. The study aims to see which method better reduces cancer deaths over time.

Who is the study for?

This trial is for men and women aged 50-75, preferably veterans, who can consent to the study. It's not for those with severe health issues that make screening risky or unnecessary, pregnant individuals, people without a stable address, or anyone with a recent history of colon disease or tests.

What is being tested?

The CONFIRM trial is comparing two colorectal cancer screening methods: annual fecal immunochemical tests (FIT) and colonoscopy. The goal is to see which method better reduces death from this cancer over ten years in people at average risk.

What are the potential side effects?

Colonoscopy may cause complications like bleeding or tears in the colon wall; however these are rare. FIT involves collecting stool samples at home and has no direct side effects but may lead to further testing if results are positive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of colon issues like IBD, polyps, cancer, or surgery.

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I have had a colon check-up in the recommended timeframe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

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

The is colorectal cancer mortality.

Secondary study objectives

FIT Positive - If Colonoscopy is Warranted

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 Intervention

FIT (annually)

Group II: Arm 1Experimental Treatment1 Intervention

Colonoscopy (one time screening)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FIT

2022

Completed Phase 2

~13520

Colonoscopy

2012

Completed Phase 3

~115560

0 / 3Eligibility criteria met

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

Colonoscopy is a critical tool in colorectal cancer treatment as it allows for direct visualization of the colonic mucosa and the removal of colorectal adenomas, which are precursors to cancer. This early intervention can prevent the progression to invasive cancer. Adjuvant chemotherapy, particularly fluorouracil (FU)-based regimens, works by inhibiting DNA synthesis in rapidly dividing cancer cells, thereby reducing tumor growth and recurrence. Oxaliplatin, often added to FU-based regimens, causes DNA crosslinking and apoptosis in cancer cells. These treatments are essential for colorectal cancer patients as they significantly reduce the risk of cancer recurrence and improve survival rates.

Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial.Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.Is laparoscopic resection appropriate for colorectal adenocarcinoma?