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Trial Title:
The Effect of Ablation Therapy on Barrett's Esophagus
NCT ID:
NCT00587314
Condition:
Barrett's Esophagus
Early Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Barrett Esophagus
Conditions: Keywords:
Photodynamic Therapy
Barrett's Esophagus
Early Esophageal Adenocarcinoma
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Biopsy
Description:
Biopsies for research purposes will be obtained when returning for clinically indicated
surveillance of Barrett's Esophagus
Arm group label:
1
Summary:
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation
) on 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.
Criteria for eligibility:
Study pop:
Patients who have had or qualify for ablation therapy for treatment of their barrett's
esophagus
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Start date:
January 2004
Completion date:
January 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00587314
