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Trial record 34 of 223 for:    "Barrett syndrome"

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

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ClinicalTrials.gov Identifier: NCT02560623
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : March 27, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 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 : November 2018
Estimated Study Completion Date : June 2019

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.



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Ages Eligible for Study:   18 Years to 85 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 - 85.
  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 5 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 5 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
Contact: Michele L Johnson, CCRP 507-293-5307 johnson.michele@mayo.edu

Locations
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Cayer Frances (Betsy), CCRP    904-953-2255    Cayer.Frances@mayo.edu   
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson    507-255-8692    johnson.michele@mayo.edu   
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson    507-293-5307      
Principal Investigator: Prasad G Iyer, MD         
Sponsors and Collaborators
Mayo Clinic
Exact Sciences Corporation
Investigators
Principal Investigator: Prasad G Iyer, MD Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02560623     History of Changes
Other Study ID Numbers: 15-004540
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
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:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases