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The Effect of Ablation Therapy on Barrett's Esophagus (ablation IN BE)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587314
First Posted: January 7, 2008
Last Update Posted: January 25, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
  Purpose
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Condition Intervention
Barrett's Esophagus Early Esophageal Adenocarcinoma Other: Biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Ablation Therapy on Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Kenneth K. Wang, Mayo Clinic:

Primary Outcome Measures:
  • Response to treatment [ Time Frame: at time of surveillance intervals ]
    presence of persistent or recurrence of barrett's esophagus and/or dysplasia


Biospecimen Retention:   Samples Without DNA
Esophageal Biopsy

Estimated Enrollment: 400
Study Start Date: January 2004
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study
Other: Biopsy
Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus

Detailed Description:
To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus
Criteria

Inclusion Criteria:

  • Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
  • Ability to provide informed consent

Exclusion Criteria:

  • Eastern Cooperative Oncology Group performance status 3 or 4
  • Inability to tolerate endoscopic procedures
  • Pregnancy: Females of child-bearing age will be screened with pregnancy test.
  Contacts and Locations
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): NCT00587314


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Kenneth K. Wang, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587314     History of Changes
Other Study ID Numbers: 258-04
First Submitted: December 21, 2007
First Posted: January 7, 2008
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Kenneth K. Wang, Mayo Clinic:
Photodynamic Therapy
Barrett's Esophagus
Early Esophageal Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms