Trial record 7 of 1253 for:    "Mayo Clinic" [Exact]

Biomarkers in Phototherapy of Barrett's Esophagus (BIOBAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587600
First received: December 21, 2007
Last updated: May 9, 2014
Last verified: May 2014

December 21, 2007
May 9, 2014
December 2002
September 2012   (final data collection date for primary outcome measure)
The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587600 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Biomarkers in Phototherapy of Barrett's Esophagus
Biomarkers in Phototherapy of Barrett's Esophagus

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Barrett's Esophagus
  • High Grade Dysplasia
  • Procedure: Photodynamic therapy
    Photofrin 2mg/kg Photoradiation The light dose delivered will be a total of 200 joules per centimeter fiber which has previously been shown to ablate Barrett's mucosa.
  • Procedure: radiofrequency ablation of barrett's esophagus
    radiofrequency ablation
  • Active Comparator: Photodynamic therapy
    will have photodynamic therapy
    Intervention: Procedure: Photodynamic therapy
  • Active Comparator: radiofrequency ablation of barretts esophagus
    radiofrequency ablation of barretts esophagus
    Intervention: Procedure: radiofrequency ablation of barrett's esophagus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
208
September 2014
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587600
2138-00, CA97048-05
Yes
Kenneth K. Wang, Mayo Clinic
Mayo Clinic
National Institutes of Health (NIH)
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
Mayo Clinic
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP