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| Sponsored by: |
Mayo Clinic |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00587314 |
Purpose
To assess the effect of ablative therapy (Photodynamic Therapy) on Barrett's Esophagus
| Condition | Intervention |
|
Barrett's Esophagus Early Esophageal Adenocarcinoma |
Biological: Biopsy |
| MedlinePlus related topics: | Esophagus Disorders |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | The Effect of Ablation Therapy on Barrett's Esophagus |
Esophageal Biopsy
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (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 photodynamic therapy
|
Biological: Biopsy
biopsy when return for clinically indicated surveillance of Barrett's Esophagus
|
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 |
Patients who have had or qualify for photodynamic therapy for treatment of their barrett's esophagus
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kenneth K Wang, MD | 507-255-7495 | barretts@mayo.edu |
| Contact: Lori S Lutzke | 507-255-7495 | lutzke.lori@mayo.edu |
| United States, Minnesota | |||||
| Mayo Clinic | Recruiting | ||||
| Rochester, Minnesota, United States, 55905 | |||||
| Contact: Lori S Lutzke 507-255-7495 lutzke.lori@mayo.edu | |||||
| Mayo Clinic |
| Principal Investigator: | Kenneth K Wang, MD | Mayo Clinic |
More Information
research web site
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| Responsible Party: | Mayo Clinic ( Kenneth K Wang MD ) |
| Study ID Numbers: | 258-04 |
| First Received: | December 21, 2007 |
| Last Updated: | January 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00587314 |
| Health Authority: | United States: Institutional Review Board |
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