Barrett's Esophagus Clinical Trial
— BIOBAROfficial title:
Biomarkers in Phototherapy of Barrett's Esophagus
Verified date | November 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomarkers (abnormalities in molecules of cells that may or may not help predict cancer) present in their Barrett's esophagus as for patients who do not have biomarkers.
Status | Completed |
Enrollment | 208 |
Est. completion date | April 21, 2017 |
Est. primary completion date | April 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - All patients will have biopsy proven Barrett's esophagus with evidence of specialized intestinal epithelium and dysplasia (either high grade dysplasia or low grade dysplasia) on histology. - Patients must have endoscopically visible segments of Barrett's esophagus of greater than 1 centimeter in length. - All patients must be eligible for longterm follow-up as well as tolerate endoscopy, biopsy, and cytology. - Patients must be willing to travel to Rochester, Minnesota for follow-up - Patients must have a friend or relative accompany them on visits since sedatives will render them unable to operate a motor vehicle - If patients are on anticoagulation, they must be able to tolerate reversal of anticoagulation for study biopsies and therapy - All patients must be able to tolerate proton pump inhibitor therapy. Esomeprazole will be provided but can be changed to another proton pump inhibitor if the patient is intolerant. - All patients who have histological or cytological evidence of high grade dysplasia will be seen by an experienced thoracic surgeon for consideration of esophagectomy. Exclusion Criteria: - Patients who are unable to follow light avoidance instructions - Patients with a history of prior esophageal surgery or successful fundoplication - Patients who had prior photodynamic therapy - Patients with pre-existing strictures in their esophagus - Patients who have known allergies to porphyrin compounds - Patients with a prior biopsies of Barrett's esophagus that contain carcinoma - Patients who require continuous anti-coagulation - Patients who are pregnant or are capable of pregnancy will be excluded from this study unless they have been on effective birth control measures - Lactating mothers are excluded from this study as it is unclear whether the photosensitizer sodium porfimer can cross to the feeding infant - Patients with underlying liver disease are excluded since their metabolism of porphyrin based photosensitizers is uncertain. Evidence of liver disease will be an transaminase elevation of three times normal, a bilirubin increase of twice normal, or an alkaline phosphatase (liver fraction) elevation of twice normal. - Patients who have underlying medical conditions that are felt to limit their survival to less than one year. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy. | 12 months | ||
Secondary | The primary assessment for our second specific aim will be to assess if specific biomarkers can be correlated with the confirmed histological elimination of their Barrett's esophagus. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02864043 -
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
|
N/A | |
Recruiting |
NCT02018367 -
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
|
Phase 2 | |
Terminated |
NCT01572987 -
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
|
N/A | |
Terminated |
NCT01976351 -
Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus
|
N/A | |
Terminated |
NCT00526786 -
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
|
Phase 4 | |
Completed |
NCT01401699 -
Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
|
N/A | |
Completed |
NCT02106910 -
Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy
|
N/A | |
Suspended |
NCT01580631 -
Narrow Band Imaging Project on Barrett's Esophagus
|
||
Completed |
NCT01439633 -
Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
|
N/A | |
Completed |
NCT02879721 -
Expression and Function of the Renin-Angiotensin System in the Esophagus
|
Phase 0 | |
Completed |
NCT01281618 -
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
|
N/A | |
Completed |
NCT01439594 -
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
|
N/A | |
Completed |
NCT00586872 -
Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
|
||
Completed |
NCT00844077 -
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
|
N/A | |
Completed |
NCT00588575 -
Ramanspectroscopy in Barrett's Esophagus
|
||
Recruiting |
NCT00288119 -
Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
|
||
Completed |
NCT03813381 -
CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).
|
N/A | |
Completed |
NCT02579460 -
Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition
|
N/A | |
Not yet recruiting |
NCT02033070 -
Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System
|
N/A | |
Completed |
NCT01961778 -
Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma
|
N/A |