- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521285
Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation
Effect of Aspirin on Biomarkers of Barrett's Esophagus After Successful Eradication of Barrett's Esophagus With Radiofrequency Ablation
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To conduct a randomized, double blind, placebo-controlled phase II chemoprevention trial, investigating whether supplementation with aspirin 325 mg/day for 12 months is safe and reduces the expression of CDX2 messenger ribonucleic acid (mRNA) (a biomarker which has been associated with the risk of developing Barrett's esophagus [BE]) in comparison to placebo after successful radiofrequency ablation (RFA).
SECONDARY OBJECTIVES:
I. To assess safety at 12 months. II. To assess differences in the expression of CDX2 at 18 months, activation status of NF-kB by assessing levels of total and phosphorylated (phospho)-p65 and cytoplasmic to nuclear translocation of phospho-p65 which is likely to be affected by aspirin.
III. To assess the prostanoid marker, prostaglandin E2, and prostaglandin synthases, which are known to respond to aspirin and to correlation with clinicopathological factors in the esophageal cancer.
IV. To assess differences in the expression of proinflammatory cytokines known to induce activation of NFkB, i.e., TNFalpha, IL-1beta, IL-6, IL-10, IL-17A, IL-23 will be measured.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive aspirin orally (PO) once daily (QD) for 12 months.
ARM B: Patients receive placebo PO QD for 12 months.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, and 18 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- Saint Michael's Hospital
-
-
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- UCHealth University of Colorado Hospital
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Missouri
-
Kansas City, Missouri, United States, 64128
- Kansas City Veterans Affairs Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania/Abramson Cancer Center
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Houston, Texas, United States, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Known diagnosis of histologically-confirmed BE with or without dysplasia (as defined by the presence of specialized columnar epithelium anywhere in the tubular esophagus with >= 1 cm of circumferential involvement or non-circumferential involvement of specialized columnar epithelium) requiring radiofrequency ablation
- Documentation of complete ablation of BE after radiofrequency ablation on two endoscopic examinations at least 3 months apart (including no evidence of BE on surveillance biopsies) as determined by the pathologist at each site; completion of ablation should have occurred no greater than 36 months prior to randomization
- The effects of the candidate chemoprevention agents on the developing human fetus remain incompletely defined; for this reason, persons of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a participant become pregnant or suspect she is pregnant while participating in this trial, she should inform the research personnel and her clinical care provider immediately
- Willingness to provide tissue samples for research purposes
- No chronic use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors during one month prior to randomization; chronic use is defined as any aspirin or NSAID use on >= 7 days during one month preceding the beginning of randomization
- Hemoglobin >= 10 g/dL or hematocrit >= 30% (obtained =< 45 days prior to randomization)
- Leukocyte count >= 3,000/microliter (obtained =< 45 days prior to randomization)
- Platelet count >= 100,000/microliter (obtained =< 45 days prior to randomization)
- Absolute neutrophil count >= 1,500/microliter (obtained =< 45 days prior to randomization)
- Creatinine =< 2.5 x institutional upper limit of normal (ULN) (obtained =< 45 days prior to randomization)
- OR glomerular filtration rate (GFR) > 30 ml/min/1.73 m^2 (obtained =< 45 days prior to randomization)
- Total bilirubin =< 2 x institutional ULN (obtained =< 45 days prior to randomization)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x institutional ULN (obtained =< 45 days prior to randomization)
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 45 days prior to randomization)
- A negative serum pregnancy test at baseline, but within 21 days of randomization, for persons of childbearing potential only
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Ability to understand and the willingness to sign a written informed consent document; a legally authorized representative (LAR) may sign informed consent for persons who do not have the capacity to legally consent to take part in the study
Exclusion Criteria:
- Inability to abstain from, NSAID (including aspirin), and selective COX-2 inhibitor therapy at the time of randomization through the completion of the study (the study period is defined as baseline to exit endoscopy at 18 months after randomization which defines the completion of the study); participants may take Tylenol and non-NSAID pain relievers
- Current or planned use of anticoagulant drugs such as: warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox throughout the course of the study
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 1 month prior to starting aspirin or placebo on this study; consultation with the participant's primary care provider will be obtained prior to stopping any agent; the use of the following drugs or drug classes is prohibited during aspirin/placebo treatment:
- NSAIDs: such as aspirin, Naprosyn, ketorolac and others NSAIDs
- COX-2 inhibitors: such as celecoxib, rofecoxib
- Valproic acid
- Sulfinpyrazone
- Probenecid
- Corticosteroids (other than short-term use defined as less than 2 weeks or pro re nata [prn (when necessary)] use of an inhaler less than twice per month)
- Platelet aggregation inhibitors, except in a monitored antithrombotic regimen
- Methotrexate (MTX)
- Vaccines containing live viruses
- Gingko
- Individuals with uncontrolled renal insufficiency or renal failure
- Participants with fundoplication within the past year, bariatric surgery or any other major upper gastrointestinal (GI) surgery; fundoplication more than one year ago will not be grounds for exclusion; cholecystectomy will not be grounds for exclusion
- History of invasive cancer diagnosis =< 12 months prior to randomization, excepting nonmelanoma skin cancer; patients with T1a adenocarcinoma of the esophagus arising in the setting of Barrett's esophagus are eligible for enrollment in the trial
- History of cancer treatment =< 12 months prior to randomization, excepting hormonal therapy (except treatment for non-melanoma skin cancer or carcinoma-in-situ of the cervix)
- Receipt of any other investigational agents =< 3 months prior to randomization, except innocuous agents with no known interaction with the study agents (e.g., standard dose multivitamins or topical agents for limited skin conditions), at the discretion of the protocol lead investigator at each participating site
- History of allergic reactions attributed to aspirin or compounds of similar chemical or biologic composition to the study agent
- History of endoscopically or radiographically diagnosed peptic ulcer disease with upper GI bleeding during the past 5 years or history of endoscopically or radiographically diagnosed peptic ulcer disease with upper GI bleeding any time while taking aspirin
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bleeding disorder, vitamin K deficiency, alcohol abuse (defined as ingestion of 3 or more drinks per day) or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women
- Breast feeding women
- Surveillance biopsies demonstrating residual BE at qualifying exam
- Presence of an esophageal stricture defined as "any recognizable change in esophageal luminal caliber that is accompanied by symptoms of dysphagia, or any asymptomatic narrowing that either will not allow any adult endoscope to pass or allows passage with resistance"
- Patients with human immunodeficiency virus (HIV) infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (aspirin)
Patients receive aspirin PO QD for 12 months.
|
Correlative studies
Given PO
Other Names:
Ancillary studies
|
Placebo Comparator: Arm B (placebo)
Patients receive placebo PO QD for 12 months.
|
Correlative studies
Ancillary studies
Given PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values in percentage of biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction.)
The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
|
Baseline and 12 months
|
Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo (Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
|
Baseline and 12 months
|
Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo ( Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
|
Baseline and 12 months
|
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction.
The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
|
Baseline and 12 months
|
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment)The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
|
Baseline and 12 months
|
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AE)
Time Frame: Up to 18 months
|
Number of Participants experiencing adverse events by maximum grade (grades 1-3).
Safety assessed by comparison of adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
AEs will be assessed according to the CTCAE grade associated with the AE term.
All adverse events are listed in the Adverse Events Overview.
|
Up to 18 months
|
Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location A)
Time Frame: Baseline to 18 months
|
Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction.
The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
|
Baseline to 18 months
|
Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location B)
Time Frame: Up to 18 months
|
Measured change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
|
Up to 18 months
|
Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location C)
Time Frame: Baseline to 18 months
|
Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
|
Baseline to 18 months
|
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location A)
Time Frame: Baseline up to 18 months
|
Measured the change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction.
The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
|
Baseline up to 18 months
|
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location B)
Time Frame: Baseline up to 18 months
|
Measured the change in the biomarker levels of p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
|
Baseline up to 18 months
|
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location C)
Time Frame: Baseline up to 18 months
|
Measured the change in the biomarker levels p-p65/total p65 in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
|
Baseline up to 18 months
|
Differences in the Change of txb2 at 12 Months (Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction.
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of tbx2 at 12 Months (Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of tbx2 at 12 Months (Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of pge1 at 12 Months ( Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of pge1 at 12 Months (Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of pge1 at 12 Months (Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of pge2 at 12 Months (Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of pge2 at 12 Months (Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change in pge2 at 12 Months (Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of a13pge1 at 12 Months (Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of a13pge1 at 12 Months ( Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change in a13pge1 at 12 Months (Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of a13pge2 at 12 Months (Location A)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of a13pge2 at 12month (Location B)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Differences in the Change of a13pge2 at 12 Months (Location C)
Time Frame: Baseline and 12 months
|
Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment).
The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.
|
Baseline and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in the Prostanoid Marker, Prostaglandin E2, and Prostaglandin Synthases
Time Frame: Baseline up to 18 months
|
Listed separately as #7-13 Secondary Outcome Measures.
|
Baseline up to 18 months
|
Differences in the Expression of Proinflammatory Cytokines Known to Induce Activation of NFkB
Time Frame: Baseline up to 18 months
|
Baseline up to 18 months
|
|
Incidence of Barrett's Esophagus (BE) Recurrence
Time Frame: Baseline up to 18 months
|
Baseline up to 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert S Bresalier, M.D. Anderson Cancer Center
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Gastrointestinal Diseases
- Esophageal Diseases
- Precancerous Conditions
- Barrett Esophagus
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- NCI-2015-01265 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA016672 (U.S. NIH Grant/Contract)
- HHSN261201200034I
- N01-CN-2012-00034 (CTRP (Clinical Trial Reporting Program))
- N01CN00034 (U.S. NIH Grant/Contract)
- 2013-0819
- 2015-0819 (Other Identifier: M D Anderson Cancer Center)
- MDA2013-02-02 (Other Identifier: DCP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Barrett Esophagus
-
Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedTerminatedBarrett's Esophagus | High-grade Dysplasia in Barrett Esophagus | Low Grade Dysplasia in Barrett EsophagusUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedBarrett Esophagus | Barrett AdenocarcinomaNetherlands
-
Mayo ClinicTerminatedBarretts Esophagus With High Grade Dysplasia | Barrett AdenocarcinomaUnited States
-
University Medical Center GroningenCompletedEsophageal Cancer | Barrett Esophagus | Dysplasia in Barrett EsophagusNetherlands
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Catharina... and other collaboratorsNot yet recruitingEsophageal Cancer | Barrett Adenocarcinoma | Barretts Esophagus With Dysplasia
-
Portsmouth Hospitals NHS TrustUniversity of PortsmouthUnknownBarrett Esophagus | Barrett Adenocarcinoma | Barrett Metaplasia | Barrett Oesophagitis With DysplasiaUnited Kingdom
-
Professor Michael BourkeWithdrawn
-
Medical University of South CarolinaCompletedBarretts Esophagus With DysplasiaUnited States
-
Allegheny Singer Research Institute (also known...Integra LifeSciences CorporationTerminatedBarrett Esophagus | High Grade Dysplasia | EsophagusUnited States
-
City of Hope Medical CenterRecruitingEsophageal Cancer | Esophageal Neoplasms | Gastroesophageal Reflux | Barrett Esophagus | Esophageal Adenocarcinoma | Reflux Disease | Barretts Esophagus With High Grade Dysplasia | Barrett Adenocarcinoma | Esophagus Cancer | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With Dysplasia | Esophagus... and other conditionsUnited States
Clinical Trials on Laboratory Biomarker Analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States