Esophageal Cancer Clinical Trial

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma

Summary

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.

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Full Description

The SOS device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from a sponge on a string (SOS) device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria arm 1:

Male and female ages 50-85
Primary Care patients from Mayo Clinic Rochester or Mayo Clinic Health Systems.
Patients who have three or more risk factors for Barrett's Esophagus.

Exclusion Criteria arm 1:

History of Barrett's esophagus or esophageal adenocarcinoma.
Prior endoscopy in the last 5 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/endoscopy 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/endoscopy procedure (Visit 2 and 3).
Patients with history of known esophageal/gastric varices or cirrhosis.
Patients with history of esophageal resection due to carcinoma.
Patients with congenital or acquired bleeding diatheses.
Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Inclusion criteria arm 2:

Subjects with known or suspected BE (cases).

Patient between the ages 18 - 90.
Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
Undergoing clinically indicated endoscopy.
Subjects without known history of BE (controls). 1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria arm 2:

Subjects with known BE.

Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
Patients with history of esophageal resection for esophageal carcinoma.

For subjects with or without known evidence of BE (on history or review of medical records):

Pregnant or lactating females.
Patients who are unable to consent.
Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
History of eosinophilic esophagitis, achalasia.
Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
Patients with history of known esophageal or gastric varices or cirrhosis.
Patients with history of surgical esophageal resection for esophageal carcinoma.
Patients with congenital or acquired bleeding diatheses.
Patients with a history of esophageal squamous dysplasia.
Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

1350

Study ID:

NCT03961945

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There are 7 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States More Info
Katelyn Valdez
Contact
480-301-6542
[email protected]
Francisco Ramirez, MD
Principal Investigator
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States More Info
Kristen Lozano
Contact
904-953-4725
L[email protected]
Herbert Wolfsen, MD
Principal Investigator
Mayo Clinic Health Systems - Austin
Austin Minnesota, 55912, United States More Info
Ramona Lansing, RN
Contact
507-538-4974
[email protected]
Eduardo Antpack, MD
Principal Investigator
Mayo Clinic Health Systems - Mankato
Mankato Minnesota, 56001, United States More Info
Ramona Lansing, RN
Contact
507-538-4974
[email protected]
Grace Dosanjh, MD
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Erin E Gibbons, BS
Contact
507-255-8692
[email protected]
Ramona Lansing, RN
Contact
507-538-4974
[email protected]
Prasad G Iyer, MD
Principal Investigator
Northwell Health
New Hyde Park New York, 11040, United States More Info
Molly Stewart
Contact
516-600-1443
[email protected]
Arvind Trindade, MD
Principal Investigator
Baylor Scott & White Research Institute
Dallas Texas, 75246, United States More Info
Shamel Brown
Contact
214-818-2528
[email protected]
Felicia Padilla
Contact
214-820-1771
[email protected]
Vani Konda, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

1350

Study ID:

NCT03961945

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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