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Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02560623
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Exact Sciences Corporation
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic

Brief Summary:
This study will evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Device: Sponge capsule Not Applicable

Detailed Description:
Assess the sensitivity and specificity of a panel of DNA methylation markers in the non-endoscopic detection of Barrett's Esophagus as well as dysplasia/carcinoma using a capsule sponge device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
Study Start Date : October 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Active Comparator: Cases - Barrett's Esophagus
Subjects will have sponge capsule procedure, blood draw, and clinically indicated endoscopy with endoscopic brushings of the esophagus.
Device: Sponge capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Other Name: EsophaCap

Active Comparator: Controls - No Barrett's Esophagus
Subjects will have sponge capsule procedure, blood draw, and clinically indicated endoscopy with endoscopic biopsies of the esophagus.
Device: Sponge capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Other Name: EsophaCap




Primary Outcome Measures :
  1. Sensitivity and specificity of Barrett's Esophagus Diagnosis [ Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months. ]
    The sensitivity and specificity of methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE will be assessed using endoscopic examination as a gold standard.


Secondary Outcome Measures :
  1. Sensitivity and specificity of Barrett's dysplasia detection [ Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months. ]
    The sensitivity and specificity of methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Subjects with known Barrett's Esophagus (BE).

  1. Patient between the ages 18 - 90.
  2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
  3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
  4. Undergoing clinically indicated endoscopy.

Subjects without known evidence of BE

1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria:

Subjects with known BE.

  1. Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
  2. Patients with history of esophageal or gastric resection.

Subjects with or without known evidence of BE (on history or review of medical records).

  1. Pregnant or lactating females.
  2. Patients who are unable to consent.
  3. Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
  4. Patients on oral anticoagulation including Coumadin, Warfarin.
  5. Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
  6. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
  7. Patients with history of known varices or cirrhosis.
  8. Patients with history of esophageal or gastric resection.
  9. Patients with congenital or acquired bleeding diatheses.
  10. Patients with a history of esophageal squamous dysplasia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560623


Contacts
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Contact: Michele L Johnson, CCRP 507-255-8692 johnson.michele@mayo.edu

Locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Pooja Bhakta    480-301-4226    bhakta.pooja@mayo.edu   
Principal Investigator: Francisco Ramirez, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Cayer Frances (Betsy), CCRP    904-953-2255    Cayer.Frances@mayo.edu   
Principal Investigator: Herbert Wolfsen, MD         
United States, Minnesota
Mayo Clinic Health Systems - Austin Recruiting
Austin, Minnesota, United States, 55912
Contact: Michele L Johnson    507-255-8692    johnson.michele@mayo.edu   
Principal Investigator: James Burke, MD         
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson, CCRP    507-255-8692    johnson.michele@mayo.edu   
Principal Investigator: Prasad G Iyer, MD         
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Molly Stewart    516-600-1443    mstewart8@northwell.edu   
Principal Investigator: Arvind Trindade, MD         
Sponsors and Collaborators
Mayo Clinic
Exact Sciences Corporation
Investigators
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Principal Investigator: Prasad G Iyer, MD Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02560623    
Other Study ID Numbers: 15-004540
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prasad G. Iyer, Mayo Clinic:
Barrett's
esophagus
reflux
esophageal adenocarcinoma
Additional relevant MeSH terms:
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Barrett Esophagus
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases