Barrett's EsophagusPhase 2/3BIOBARNCT00587600
Biomarkers in Phototherapy of Barrett's Esophagus
A Phase 2/3 study testing Photodynamic therapy and radiofrequency ablation of barrett's esophagus in people with Barrett's Esophagus and High Grade Dysplasia, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barrett's Esophagus, High Grade Dysplasia
- What is being tested?
- Photodynamic therapy and radiofrequency ablation of barrett's esophagus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to 21 Apr 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Barrett's Esophagus, High Grade Dysplasia
- Being tested
- Photodynamic therapy, radiofrequency ablation of barrett's esophagus
- Keywords
- Barrett's Esophagus, High Grade Dysplasia, Photodynamic Therapy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
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.
radiofrequency ablation of barrett's esophagusProcedure or surgery
radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy | Active comparator | will have photodynamic therapy Receives: Procedure: Photodynamic therapy |
| radiofrequency ablation of barretts esophagus | Active comparator | radiofrequency ablation of barretts esophagus Receives: Procedure: radiofrequency ablation of barrett's esophagus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startDec 2002
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kenneth K. Wang, Mayo Clinic
- Investigators
- Kenneth K Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587600
- Sponsor's protocol ID
- 2138-00
- Other IDs
- CA97048-05
- Acronym
- BIOBAR
- Status last verified
- Nov 2017
- First submitted
- 21 Dec 2007
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Phototherapy of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00587600
- Acronym / sponsor ID
- BIOBAR / 2138-00
- Conditions
- Barrett's Esophagus, High Grade Dysplasia
- Keywords
- Barrett's Esophagus, High Grade Dysplasia, Photodynamic Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2002
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy | Active comparator | Procedure: Photodynamic therapywill have photodynamic therapy |
| radiofrequency ablation of barretts esophagus | Active comparator | Procedure: radiofrequency ablation of barrett's esophagusradiofrequency ablation of barretts esophagus |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapyPhotofrin 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 or surgery | Photodynamic therapy |
| radiofrequency ablation of barrett's esophagusradiofrequency ablation | Procedure or surgery | radiofrequency ablation of barretts esophagus |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth K Wang, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Photodynamic therapy and radiofrequency ablation of barrett's esophagus in people with Barrett's Esophagus and High Grade Dysplasia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.