Barrett EsophagusNCT07206589
Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial
A study testing Cancer Screening, Computer-Assisted Intervention and Endoscopic Procedure in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Mayo Clinic at 3 sites in United States.
Trial summary
This clinical trial studies how well minimally invasive approaches (an artificial intelligence [AI] powered risk tool, nurse navigation, and a sponge on a string [SOS] test) work in diagnosing patients with Barrett's esophagus (BE) and esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma
- What is being tested?
- Cancer Screening, Computer-Assisted Intervention and Endoscopic Procedure
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SPECIFIC AIM 1A: Adult patients 18-85 years old
- SPECIFIC AIM 1A INTERVENTION CLUSTERS: BE Risk Tool Score > 0.087, indicating a higher risk for BE/esophageal adenocarcinoma (EAC). This will be run as a web-based application integrating data from several domains in the electronic health record (EPIC). Output score will range from 0-1.
- SPECIFIC AIM 1A CONTROL CLUSTERS: Meeting American College of Gastroenterology (ACG) screening criteria (gastroesophageal reflux disease [GERD]+ > 2 BE risk factors: Age ≥ 50 years, Male sex, Caucasian race, obesity [body mass index (BMI) > 30], ever smoker, family history of BE/EAC)
- SPECIFIC AIM 1B: A "low risk" BE risk tool score (< 0.0897)
Who cannot join
- SPECIFIC AIM 1A: History of Barrett's esophagus or esophageal adenocarcinoma
- SPECIFIC AIM 1A: Prior endoscopy in the last 10 years
- SPECIFIC AIM 1A: Patients who are unable to consent
- SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia
- SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia
- SPECIFIC AIM 1A: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to the sponge procedure
Show all 26Show fewer
- SPECIFIC AIM 1A: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure
- SPECIFIC AIM 1A: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure
- SPECIFIC AIM 1A: Patients with a history of known varices or cirrhosis
- SPECIFIC AIM 1A: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
- SPECIFIC AIM 1A: Patients with congenital or acquired bleeding diatheses
- SPECIFIC AIM 1A: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma
- SPECIFIC AIM 1A: Patients with limited life expectancy (< 2 years): per provider judgement
- SPECIFIC AIM 1B: History of Barrett's esophagus or esophageal adenocarcinoma
- SPECIFIC AIM 1B: Prior endoscopy in the last 10 years
- SPECIFIC AIM 1B: Patients who are unable to consent
- SPECIFIC AIM 1B: Patients with a current history of uninvestigated dysphagia
- SPECIFIC AIM 1B: History of eosinophilic esophagitis, achalasia
- SPECIFIC AIM 1B: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to procedure
- SPECIFIC AIM 1B: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to procedure
- SPECIFIC AIM 1B: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to procedure
- SPECIFIC AIM 1B: Patients with a history of known varices or cirrhosis
- SPECIFIC AIM 1B: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
- SPECIFIC AIM 1B: Patients with congenital or acquired bleeding diatheses
- SPECIFIC AIM 1B: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma
- SPECIFIC AIM 1B: Patients with limited life expectancy (< 2 years): per provider judgement
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ramona Lansing contact
United States3 sites
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ramona Lansing, 507-538-4974, lansing.ramona@mayo.edu
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ramona Lansing, 507-538-4974, lansing.ramona@mayo.edu
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ramona Lansing, 507-538-4974, lansing.ramona@mayo.edu
About this study
Official title: Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)
This clinical trial studies how well minimally invasive approaches (an artificial intelligence [AI] powered risk tool, nurse navigation, and a sponge on a string [SOS] test) work in diagnosing patients with Barrett's esophagus (BE) and esophageal cancer. Esophageal cancer has a poor 5-year survival rate when diagnosed after onset of symptoms. While rising, incidence of esophageal cancer remains too low to screen the entire population. BE is a condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to esophageal cancer. Currently, patients are screened for BE based on certain risk factors (reflux, age > 50 years, White race, family history of esophageal cancer, obesity, male sex, and smoking), followed by endoscopies and surgery for treatment. These standard procedures may result in under-recognition of BE risk due to inaccurate and difficult to use risk assessment tools, high cost, invasiveness, low access to endoscopy, and sub-optimal recognition of abnormal cells during routing endoscopy. An AI powered risk tool that integrates symptoms, health history, and laboratory values from electronic health record data may more accurately assess BE and esophageal cancer risk that manual assessment. The BE-SOS screening test combines a swallowable cell collection device with assessment of DNA, which may more accurately diagnose abnormal cells. Nurse navigation involves trained personnel assisting individuals through the screening process and completing the follow-up diagnostic test if the screening test is positive. Navigators address cultural, social, access, and logistical barriers to screening. Nurse navigation may increase completion rates of diagnostic procedures following a positive screening test. These minimally invasive approaches may enable higher rates of BE screening than currently being accomplished.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Being tested
- Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer ScreeningOther
Also called Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of Cancer
Undergo BE-SOS test
Computer-Assisted InterventionOther
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic ProcedureProcedure or surgery
Also called Endoscopic Examination, Endoscopy, ES
Undergo endoscopy
Health Risk AssessmentBehavioural
Also called Risk Assessment
Undergo manual BE risk assessment
NavigationOther
Receive RN navigation
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (T1 SOC, T2-T4 Intervention) | Experimental | 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. Receives: Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration |
| Arm 2 (T1 SOC, T2-T4 Intervention) | Experimental | 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. Receives: Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration |
| Arm 3 (T1-T2 SOC, T3-T4 Intervention) | Experimental | 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. Receives: Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration |
| Arm 4 (T1-T2 SOC, T3-T4 Intervention) | Experimental | 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. Receives: Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration |
| Arm 5 (T1-T3 SOC, T4 Intervention) | Experimental | 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. Receives: Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration |
| Arm 6 (T1-T3 SOC, T4 Intervention) | Experimental | 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. Receives: Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completed Barrett's esophagus (BE) screening
Assessed as the proportion of patients who complete BE screening. This is determined as the number of patients who complete a sponge on a string (SOS) BE screening test or endoscopy screen, divided by the number of screen eligible patients in each group.
Measured: Baseline (completion of endoscopy)
Negative predictive value of the AI powered BE Risk Tool (Aim 1b)
A randomly selected sample of patients (N=50) with a negative BE risk tool score will undergo a research upper endoscopy to confirm the high estimated negative predicted value of the BE risk tool.
Measured: Baseline (completion of endoscopy)
Secondary outcomes (5)
BE screening ordered (completed + not completed)
Assessed as the proportion of patients who complete BE screening (SOS BE screen test or endoscopy) for patients where BE screening has been ordered.
Measured: Baseline (completion of endoscopy)
Successful completion of the SOS BE screen test
Assessed as the number that had successful test completion (a test result was received) divided by the number of patients where a BE-SOS test/endoscopy order was placed
Measured: Baseline (completion of endoscopy)
Completion of diagnostic endoscopy following a positive SOS BE screen test
Assessed as the proportion of patients who complete diagnostic endoscopy following a positive BE-SOS test.
Measured: Baseline (completion of endoscopy)
Rates of BE [with or without dysplasia/esophageal adenocarcinoma (EAC)]
The proportion of patients with BE/EAC diagnoses will be determined as the number with a BE/EAC diagnosis divided by the number of patients who underwent BE-SOS or endoscopy.
Measured: Baseline (completion of endoscopy)
Patients flagged for screening by the BE risk tool in the intervention clusters who also meet American College of Gastroenterology (ACG) BE screening guidelines
The proportion of screen eligible patients in the intervention arm who meet ACG screening criteria will be determined as the number meeting screening criteria divided by the number in the group.
Measured: Baseline (completion of endoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Dec 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Prasad G Iyer, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206589
- Sponsor's protocol ID
- SOS5C
- Other IDs
- R01CA241164, 25-002435
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)
- ClinicalTrials.gov ID
- NCT07206589
- Acronym / sponsor ID
- SOS5C
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how well minimally invasive approaches (an artificial intelligence [AI] powered risk tool, nurse navigation, and a sponge on a string [SOS] test) work in diagnosing patients with Barrett's esophagus (BE) and esophageal cancer. Esophageal cancer has a poor 5-year survival rate when diagnosed after onset of symptoms. While rising, incidence of esophageal cancer remains too low to screen the entire population. BE is a condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to esophageal cancer. Currently, patients are screened for BE based on certain risk factors (reflux, age > 50 years, White race, family history of esophageal cancer, obesity, male sex, and smoking), followed by endoscopies and surgery for treatment. These standard procedures may result in under-recognition of BE risk due to inaccurate and difficult to use risk assessment tools, high cost, invasiveness, low access to endoscopy, and sub-optimal recognition of abnormal cells during routing endoscopy. An AI powered risk tool that integrates symptoms, health history, and laboratory values from electronic health record data may more accurately assess BE and esophageal cancer risk that manual assessment. The BE-SOS screening test combines a swallowable cell collection device with assessment of DNA, which may more accurately diagnose abnormal cells. Nurse navigation involves trained personnel assisting individuals through the screening process and completing the follow-up diagnostic test if the screening test is positive. Navigators address cultural, social, access, and logistical barriers to screening. Nurse navigation may increase completion rates of diagnostic procedures following a positive screening test. These minimally invasive approaches may enable higher rates of BE screening than currently being accomplished.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (T1 SOC, T2-T4 Intervention) | Experimental | Other: Cancer Screening, Other: Computer-Assisted Intervention, Procedure: Endoscopic Procedure, Behavioral: Health Risk Assessment, Other: Navigation, Other: Questionnaire AdministrationFamily 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. |
| Arm 2 (T1 SOC, T2-T4 Intervention) | Experimental | Other: Cancer Screening, Other: Computer-Assisted Intervention, Procedure: Endoscopic Procedure, Behavioral: Health Risk Assessment, Other: Navigation, Other: Questionnaire AdministrationFamily 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. |
| Arm 3 (T1-T2 SOC, T3-T4 Intervention) | Experimental | Other: Cancer Screening, Other: Computer-Assisted Intervention, Procedure: Endoscopic Procedure, Behavioral: Health Risk Assessment, Other: Navigation, Other: Questionnaire AdministrationFamily 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. |
| Arm 4 (T1-T2 SOC, T3-T4 Intervention) | Experimental | Other: Cancer Screening, Other: Computer-Assisted Intervention, Procedure: Endoscopic Procedure, Behavioral: Health Risk Assessment, Other: Navigation, Other: Questionnaire AdministrationFamily 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. |
| Arm 5 (T1-T3 SOC, T4 Intervention) | Experimental | Other: Cancer Screening, Other: Computer-Assisted Intervention, Procedure: Endoscopic Procedure, Behavioral: Health Risk Assessment, Other: Navigation, Other: Questionnaire AdministrationFamily 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. |
| Arm 6 (T1-T3 SOC, T4 Intervention) | Experimental | Other: Cancer Screening, Other: Computer-Assisted Intervention, Procedure: Endoscopic Procedure, Behavioral: Health Risk Assessment, Other: Navigation, Other: Questionnaire AdministrationFamily 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SPECIFIC AIM 1A: Adult patients 18-85 years old
- SPECIFIC AIM 1A INTERVENTION CLUSTERS: BE Risk Tool Score > 0.087, indicating a higher risk for BE/esophageal adenocarcinoma (EAC). This will be run as a web-based application integrating data from several domains in the electronic health record (EPIC). Output score will range from 0-1.
- SPECIFIC AIM 1A CONTROL CLUSTERS: Meeting American College of Gastroenterology (ACG) screening criteria (gastroesophageal reflux disease [GERD]+ > 2 BE risk factors: Age ≥ 50 years, Male sex, Caucasian race, obesity [body mass index (BMI) > 30], ever smoker, family history of BE/EAC)
- SPECIFIC AIM 1B: A "low risk" BE risk tool score (< 0.0897)
Key exclusion criteria (26 listed)
- SPECIFIC AIM 1A: History of Barrett's esophagus or esophageal adenocarcinoma
- SPECIFIC AIM 1A: Prior endoscopy in the last 10 years
- SPECIFIC AIM 1A: Patients who are unable to consent
- SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia
- SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer ScreeningAlso: Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of CancerUndergo BE-SOS test | Other | Arm 1 (T1 SOC, T2-T4 Intervention), Arm 2 (T1 SOC, T2-T4 Intervention), Arm 3 (T1-T2 SOC, T3-T4 Intervention), Arm 4 (T1-T2 SOC, T3-T4 Intervention), Arm 5 (T1-T3 SOC, T4 Intervention), Arm 6 (T1-T3 SOC, T4 Intervention) |
| Computer-Assisted InterventionUndergo BE risk assessment using AI powered BE Risk Tool | Other | Arm 1 (T1 SOC, T2-T4 Intervention), Arm 2 (T1 SOC, T2-T4 Intervention), Arm 3 (T1-T2 SOC, T3-T4 Intervention), Arm 4 (T1-T2 SOC, T3-T4 Intervention), Arm 5 (T1-T3 SOC, T4 Intervention), Arm 6 (T1-T3 SOC, T4 Intervention) |
| Endoscopic ProcedureAlso: Endoscopic Examination, Endoscopy, ESUndergo endoscopy | Procedure or surgery | Arm 1 (T1 SOC, T2-T4 Intervention), Arm 2 (T1 SOC, T2-T4 Intervention), Arm 3 (T1-T2 SOC, T3-T4 Intervention), Arm 4 (T1-T2 SOC, T3-T4 Intervention), Arm 5 (T1-T3 SOC, T4 Intervention), Arm 6 (T1-T3 SOC, T4 Intervention) |
| Health Risk AssessmentAlso: Risk AssessmentUndergo manual BE risk assessment | Behavioural | Arm 1 (T1 SOC, T2-T4 Intervention), Arm 2 (T1 SOC, T2-T4 Intervention), Arm 3 (T1-T2 SOC, T3-T4 Intervention), Arm 4 (T1-T2 SOC, T3-T4 Intervention), Arm 5 (T1-T3 SOC, T4 Intervention), Arm 6 (T1-T3 SOC, T4 Intervention) |
| NavigationReceive RN navigation | Other | Arm 1 (T1 SOC, T2-T4 Intervention), Arm 2 (T1 SOC, T2-T4 Intervention), Arm 3 (T1-T2 SOC, T3-T4 Intervention), Arm 4 (T1-T2 SOC, T3-T4 Intervention), Arm 5 (T1-T3 SOC, T4 Intervention), Arm 6 (T1-T3 SOC, T4 Intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1 (T1 SOC, T2-T4 Intervention), Arm 2 (T1 SOC, T2-T4 Intervention), Arm 3 (T1-T2 SOC, T3-T4 Intervention), Arm 4 (T1-T2 SOC, T3-T4 Intervention), Arm 5 (T1-T3 SOC, T4 Intervention), Arm 6 (T1-T3 SOC, T4 Intervention) |
Primary outcome
Rate of completed Barrett's esophagus (BE) screening
Time frame: Baseline (completion of endoscopy)
Assessed as the proportion of patients who complete BE screening. This is determined as the number of patients who complete a sponge on a string (SOS) BE screening test or endoscopy screen, divided by the number of screen eligible patients in each group.
Negative predictive value of the AI powered BE Risk Tool (Aim 1b)
Time frame: Baseline (completion of endoscopy)
A randomly selected sample of patients (N=50) with a negative BE risk tool score will undergo a research upper endoscopy to confirm the high estimated negative predicted value of the BE risk tool.
5 secondary outcomes
BE screening ordered (completed + not completed)
Time frame: Baseline (completion of endoscopy)
Successful completion of the SOS BE screen test
Time frame: Baseline (completion of endoscopy)
Completion of diagnostic endoscopy following a positive SOS BE screen test
Time frame: Baseline (completion of endoscopy)
Rates of BE [with or without dysplasia/esophageal adenocarcinoma (EAC)]
Time frame: Baseline (completion of endoscopy)
Patients flagged for screening by the BE risk tool in the intervention clusters who also meet American College of Gastroenterology (ACG) BE screening guidelines
Time frame: Baseline (completion of endoscopy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramona Lansing contact
Prasad G Iyer, MD, MS principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Screening, Computer-Assisted Intervention and Endoscopic Procedure in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of completed Barrett's esophagus (BE) screening (time frame: Baseline (completion of endoscopy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.