What is the mechanism of action of this treatment?

The most common treatments for colorectal cancer include chemotherapy, radiotherapy, and surgical interventions. Chemotherapy uses drugs to kill or inhibit the growth of cancer cells, radiotherapy employs high-energy radiation to damage the DNA of cancer cells, and surgical interventions aim to remove the tumor and affected tissues. These treatments are essential as they directly target cancer cells, aiming to reduce tumor size, prevent metastasis, and improve survival rates. Real-time feedback in procedures like colonoscopy can enhance the detection and removal of precancerous polyps, preventing the progression to colorectal cancer.

What side effects are associated with this type of intervention?

The most common treatments for colorectal cancer include surgery, chemotherapy, and radiation therapy. Surgery, such as abdominoperineal resection (APR), can lead to complications like poor anorectal function, increased stool frequency, incontinence, and perianal irritation. Chemotherapy, often involving drugs like oxaliplatin and fluoropyrimidines, can cause side effects such as peripheral neuropathy, fatigue, nausea, and increased risk of infection. Radiation therapy can result in gastrointestinal issues like diarrhea, bowel symptoms, and fecal leakage. These treatments aim to remove or destroy cancer cells but can significantly impact the patient's quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapy agents like fluorouracil (5-FU), oxaliplatin, and irinotecan, which are often used in combination regimens such as FOLFOX and FOLFIRI. Targeted therapies like cetuximab and bevacizumab have also been approved, offering additional options for patients with metastatic disease. Real-time feedback during endoscopic examinations is being studied to improve the quality of these procedures, potentially leading to better detection and treatment outcomes.

What other types of research exist?

Promising novel alternatives to Real-time Feedback for colorectal cancer patients include: 1) Robotic-assisted rectal cancer surgery, which offers precision and potentially better outcomes compared to traditional laparoscopy. 2) The trimodal approach combining short-course radiation therapy (SC-RT) with FOLFOX chemotherapy as preoperative treatment, which has shown stable quality of life outcomes. 3) Immunotherapy, particularly PD-1 inhibitors like pembrolizumab, for patients with specific biomarkers. 4) Integration of digital Cognitive Behavioral Therapy for Insomnia (CBT-I) to improve overall well-being and treatment adherence. These alternatives are supported by recent studies and ongoing trials aiming to enhance both oncologic and functional outcomes.

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Artificial Intelligence

Real-Time Feedback AI for Colonoscopy Quality Improvement

N/A

Recruiting

Led By Piet de Groen, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

- Any endoscopist willing to parcipate and performing routine colonscopy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving doctors timely feedback during endoscopic exams can improve the quality of these procedures for patients.

Who is the study for?

This trial is for any endoscopist who is willing to participate and performs routine colonoscopy procedures. Specific details on exclusion criteria are not provided, but typically these would include factors that could interfere with the study or the safety of participants.

What is being tested?

The trial is testing an AI program designed to provide real-time feedback during colonoscopies. The goal is to see if this technology can improve the quality of endoscopic examinations potentially leading to better outcomes in colorectal cancer screening.

What are the potential side effects?

Since this trial involves a non-invasive AI tool rather than a drug or medical procedure, traditional side effects are not expected. However, there may be indirect effects related to changes in how endoscopists perform colonoscopies.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adenoma Detection Rate

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: Testing of degree of mucosal inspectionExperimental Treatment1 Intervention

AI provides real-time feedback related to circumferential views during endoscope removal

Group II: Testing of clearing of fecal debrisExperimental Treatment1 Intervention

AI provides real-time feedback related to removal of remaining fecal debris

0 / 1Eligibility 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

The most common treatments for colorectal cancer include chemotherapy, radiotherapy, and surgical interventions. Chemotherapy uses drugs to kill or inhibit the growth of cancer cells, radiotherapy employs high-energy radiation to damage the DNA of cancer cells, and surgical interventions aim to remove the tumor and affected tissues. These treatments are essential as they directly target cancer cells, aiming to reduce tumor size, prevent metastasis, and improve survival rates. Real-time feedback in procedures like colonoscopy can enhance the detection and removal of precancerous polyps, preventing the progression to colorectal cancer.

Brazilian society of surgical oncology: Guidelines for the surgical treatment of mid-low rectal cancer.A Multidisciplinary Approach for the Personalised Non-Operative Management of Elderly and Frail Rectal Cancer Patients Unable to Undergo TME Surgery.Readiness for cancer rehabilitation in Denmark: protocol for a cross-sectional mixed methods study.