Minimally Invasive Diagnosis for Barrett's Esophagus and Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new, less invasive methods for diagnosing Barrett's esophagus and esophageal cancer. It employs an AI-powered risk tool to assess risks, a swallowable sponge test (Sponge on a String, or SOS Test) to collect cells for analysis, and nurse navigators to guide patients through the process. These methods could enhance the accuracy and accessibility of screening compared to traditional endoscopies. Individuals with frequent acid reflux and at least two risk factors, such as being over 50, male, or having a family history of esophageal issues, might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could revolutionize screening methods.
Do I have to stop taking my current medications for the trial?
If you are taking blood thinners like Coumadin, Warfarin, Clopidogrel, or certain other medications like Dabigatran and factor Xa inhibitors (rivaroxaban, apixaban, edoxaban), you will need to stop them five days before the procedure. For other medications, the trial protocol does not specify any requirements.
What prior data suggests that these minimally invasive approaches are safe for diagnosing Barrett's esophagus and esophageal cancer?
Previous studies have shown that the AI-powered risk tool accurately predicts the risk of Barrett's esophagus and esophageal cancer. This tool uses advanced technology to assess risk without causing harm, and no negative effects have been reported from its use.
The Sponge on a String (SOS) test, also known as Cytosponge, has undergone thorough research. Studies have found it to be safe and well-tolerated by patients, with no negative effects reported. Most patients and doctors find the test acceptable, indicating that people generally don't mind taking it.
Both the AI tool and the SOS test are less invasive than traditional methods like endoscopy. These methods aim to improve early diagnosis, which is important for better health outcomes.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new way to diagnose Barrett's Esophagus and Esophageal Cancer using an AI-powered Risk Tool. Unlike traditional methods that rely heavily on manual assessments and invasive procedures like endoscopy, this approach leverages artificial intelligence to evaluate a patient’s risk more accurately and efficiently. By integrating RN navigators to assist patients through the process, it aims to streamline the diagnostic journey and potentially reduce the need for unnecessary endoscopies. This could lead to faster, more personalized care and better outcomes for patients.
What evidence suggests that this trial's minimally invasive approaches could be effective for diagnosing Barrett's esophagus and esophageal cancer?
This trial will evaluate different approaches for diagnosing Barrett's esophagus (BE) and esophageal cancer. Participants in various arms of this trial will experience different combinations of standard care and innovative interventions.
Studies have shown that an AI-powered risk tool, which some participants in this trial will use, can improve the accuracy of detecting BE and esophageal cancer. This tool analyzes symptoms, health history, and lab results to provide a more precise risk assessment than traditional methods. Research indicates that this approach helps identify pre-cancerous conditions earlier, potentially preventing the disease from worsening.
The "Sponge on a String" (SOS) test, another component of the trial, has also demonstrated high accuracy in diagnosing BE. Recent studies suggest it can identify ten times more people with BE compared to standard procedures. This test is less invasive than an endoscopy and could help detect BE early, making it a promising option for screening.12456Who Is on the Research Team?
Prasad G Iyer, MD, MS
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals at risk of Barrett's esophagus (BE) and esophageal cancer, particularly those over 50 years old, with reflux symptoms, obesity, a smoking history, or family history of esophageal cancer. It aims to improve diagnosis using less invasive methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Standard of Care (SOC) Procedures
Care teams manually assess BE risk for patients, and patients meeting ACG criteria are recommended to undergo BE screening with BE-SOS test followed by endoscopy (only if BE-SOS positive).
Intervention Procedures
Care teams utilize RN navigators that assist in using the AI powered BE Risk Tool to assess patients' BE risk; Patients with AI powered BE Risk Tool high risk result undergo BE-SOS test with RN navigator assistance; Patients with positive BE-SOS test results then undergo endoscopy with RN navigator facilitation.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AI-powered Risk Tool
- Nurse Navigation
- Sponge on a String (SOS) Test
Trial Overview
The study tests an AI-powered risk tool alongside nurse navigation and a 'sponge on a string' test to diagnose BE and prevent esophageal cancer. These approaches are compared against standard screening procedures like endoscopies.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Family Medicine Care Teams in Cluster F provide SOC procedures as in Arm 1 during T1, T2, and T3, followed by intervention procedures as in Arm 1 during T4.
Family Medicine Care Teams in Cluster E provide SOC procedures as in Arm 1 during T1, T2, and T3, followed by intervention procedures as in Arm 1 during T4.
Family Medicine Care Teams in Cluster D provide SOC procedures as in Arm 1 during T1 and T2, followed by intervention procedures as in Arm 1 during T3 and T4.
Family Medicine Care Teams in Cluster C provide SOC procedures as in Arm 1 during T1 and T2, followed by intervention procedures as in Arm 1 during T3 and T4.
Family Medicine Care Teams in Cluster B provide SOC procedures as in Arm 1 during T1, followed by intervention procedures as in Arm 1 during T2, T3, and T4.
Family Medicine Care Teams in Cluster A provide SOC procedures during T1 consisting of the following: 1) Care teams manually assess BE risk for patients, and patients meeting ACG criteria are recommended to undergo BE screening with BE-SOS test followed by endoscopy (only if BE-SOS positive). Family Medicine Care Teams in Cluster A then provide intervention procedures during T2, T3, and T4 consisting of the following: 1) Care teams utilize RN navigators that assist in using the AI powered BE Risk Tool to assess patients' BE risk; 2) Patients with AI powered BE Risk Tool high risk result undergo BE-SOS test with RN navigator assistance; 3) Patients with positive BE-SOS test results then undergo endoscopy with RN navigator facilitation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1.
cancerblog.mayoclinic.org
cancerblog.mayoclinic.org/2024/04/18/ai-may-help-predict-risk-of-barretts-esophagus-and-esophageal-cancer/AI may help predict risk of Barrett's esophagus and ...
"Our work has demonstrated that it's possible to create a more accurate risk assessment tool for Barrett's esophagus and esophageal cancer using ...
AI-Driven Risk Prediction Tool (TSP-9) Informs ...
AI-Driven Risk Prediction Tool (TSP-9) Informs Risk-Aligned Care for Patients ... Assessment of Barrett's Esophagus: A Tandem Randomized and Video Trial.
AI-Powered Detection of Pre-Cancerous Esophageal Cells
WATS gives me a much sharper tool to use to find the disease early and prevent the natural progression.
4.
clpmag.com
clpmag.com/disease-states/improving-barretts-esophagus-risk-stratification-with-ai-powered-spatialomics/Improving Barrett's Esophagus Risk Stratification with AI- ...
AI-powered spatialomics tools are helping clinicians to more accurately risk-stratify patients with Barrett's esophagus (BE).
Advancements in Barrett's esophagus detection: The role of ...
The ultimate goal of this AI system is to serve as a valuable tool for ... The path to early cancer prevention is becoming clearer thanks to the power of AI.
6.
michiganmedicine.org
michiganmedicine.org/health-lab/ai-can-predict-certain-forms-esophageal-and-stomach-cancerAI can predict certain forms of esophageal and stomach cancer
“Our devoted team was able to use sophisticated machine learning tools to develop this unique tool, and we are very excited that this could ...
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