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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Mayo Clinic
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic Identifier:
First received: December 21, 2007
Last updated: August 26, 2015
Last verified: August 2015
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 Mayo Clinic:

Primary Outcome Measures:
  • Response to treatment [ Time Frame: at time of surveillance intervals ] [ Designated as safety issue: No ]
    presence of persistent or recurrence of barrett's esophagus and/or dysplasia

Biospecimen Retention:   Samples Without DNA
Esophageal Biopsy

Estimated Enrollment: 300
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
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.

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00587314

Contact: Kenneth K Wang, MD 507-255-7495
Contact: Lori S Lutzke 507-255-7495

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori S Lutzke    507-255-7495   
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth K. Wang, MD, Mayo Clinic Identifier: NCT00587314     History of Changes
Other Study ID Numbers: 258-04
Study First Received: December 21, 2007
Last Updated: August 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Photodynamic Therapy
Barrett's Esophagus
Early Esophageal Adenocarcinoma

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on November 30, 2015