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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA241164 | U.S. NIH Grant/Contract | View source | |
| 25-002435 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Screening | Other | Undergo BE-SOS test |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (completion of endoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (completion of endoscopy) |
| Successful completion of the SOS BE screen test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Ramona Lansing | Contact | 507-538-4974 | lansing.ramona@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Prasad G Iyer, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| 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. |
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| 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. |
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| 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. |
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| Computer-Assisted Intervention | Other | Undergo BE risk assessment using AI powered BE Risk Tool |
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| Endoscopic Procedure | Procedure | Undergo endoscopy |
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| Health Risk Assessment | Behavioral | Undergo manual BE risk assessment |
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| Navigation | Other | Receive RN navigation |
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| Questionnaire Administration | Other | Ancillary studies |
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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 |
| 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. | 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. | 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. | Baseline (completion of endoscopy) |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | 54701 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D004724 | Endoscopy |
| D018570 | Risk Assessment |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D012308 | Risk Management |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D015991 | Epidemiologic Measurements |
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