The Effect of Ablation Therapy on Barrett's Esophagus (ablation IN BE)
This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587314
First received: December 21, 2007
Last updated: November 6, 2012
Last verified: November 2012
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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 |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Biospecimen Retention: Samples Without DNA
Detailed Description:
Esophageal Biopsy
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (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
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: | November 6, 2012 |
| 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 Adenocarcinoma, Mucinous Barrett Esophagus Esophageal Diseases Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013