Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-002629
- Mankato, Minnesota: 19-002629
- La Crosse, Wisconsin: 19-002629
- Jacksonville, Florida: 19-002629
- Eau Claire, Wisconsin: 19-002629
- Austin, Minnesota: 19-002629
- Scottsdale/Phoenix, Arizona: 19-002629
NCT ID: NCT03961945
Sponsor Protocol Number: 19-002629
About this study
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All participants will be 50 years of age or older and younger than 85 years of age.
- All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
- Other risk factors considered would include:
- Caucasian race;
- History of ever smoking (current or prior history of smoking);
- BMI greater than equal to 30;
- Family history of Barrett's esophagus or esophageal adenocarcinoma;
- Male sex.
Exclusion Criteria:
- History of Barrett's esophagus or esophageal adenocarcinoma.
- Prior endoscopy in the last 10 years.
- Pregnant or lactating females.
- Patients who are unable to consent.
- Patients with current history of uninvestigated dysphagia
- History of eosinophilic esophagitis, achalasia.
- Patients on oral anticoagulation including Coumadin, Warfarin.
- Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
- Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
- Patients with history of known varices or cirrhosis.
- Patients with history of esophageal or gastric resection.
- Patients with congenital or acquired bleeding diatheses.
- Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
- Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Prasad Iyer, M.D., M.S. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Mankato, Minn.
Mayo Clinic principal investigator Prabhjot Dosanjh, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
La Crosse, Wis.
Mayo Clinic principal investigator Sebastian Strobel, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Herbert Wolfsen, M.D. |
Closed for enrollment |
Contact information:
Herbert Wolfsen M.D.
(904)953-6970
Contact UsWolfsen.Herbert@mayo.edu
|
Eau Claire, Wis.
Mayo Clinic principal investigator Sushil Kumar Garg, M.B.B.S. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Austin, Minn.
Mayo Clinic principal investigator Eduardo Antpack Filho, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Francisco Ramirez, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available