Trial record 20 of 141 for:    "Barrett syndrome"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587314
First received: December 21, 2007
Last updated: July 29, 2014
Last verified: July 2014
  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
Biological: Biopsy

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

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 2018
Estimated Primary Completion Date: January 2017 (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
Biological: Biopsy
biopsy when return 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

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

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
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 ClinicalTrials.gov identifier: NCT00587314

Contacts
Contact: Kenneth K Wang, MD 507-255-7495 wang.kenneth@mayo.edu
Contact: Lori S Lutzke 507-255-7495 lutzke.lori@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori S Lutzke    507-255-7495    lutzke.lori@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth K. Wang, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587314     History of Changes
Other Study ID Numbers: 258-04
Study First Received: December 21, 2007
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 29, 2014