14 Clinical Trials for Various Conditions
Treat Barrett's esophagus (BE) patients with tamoxifen to Barrett's metaplasia as measured by changes in Barrett's esophagus appearance by endoscopy and histology as well as changes in SOX2 and CDX2.
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions: 1. can this zinc administration cause molecular-level changes in the Barrett's tissue? 2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for all patients, followed by Esophagogastroduodenoscopy (EGD) with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1 or 3 months. A complete response (CR) was defined as all biopsy specimens negative for Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the 2.5-year follow-up,the results of which were published . There is ample evidence that RadioFrequency Ablation (RFA) for Barrett's esophagus is effective and safe. Having additional follow-up (5 years) would add valuable information to the literature, thus aiding the physician in making patient management decisions about the appropriate follow-up interval after RFA.
The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.
Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia without dysplasia to look for predictive factors for transformation to dysplasia or cancer. Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and Normal esophageal mucosa. In addition, the investigators are testing a brushing technique from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's intestinal metaplasia without history of dysplasia to be on this longitudinal study.
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or \<50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.
This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).
Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab for analysis of a validated biomarker panel. Subjects will be stratified to either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia will receive surveillance endoscopy in 1 year per routine care. All subjects will be administered a questionnaire seeking information about hypothetical willingness to be randomized to treatment or surveillance.
The goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus. Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy (EGD). Participants complete a questionnaire, have body measurements obtained, and have blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH impedance test.
The investigators propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett's Esophagus (BE) subjects.
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.
The purpose of this study is to determine if the intervention of a 510(k)-cleared endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is better than anti-secretory therapy alone in clearing Barrett's Esophagus.
We propose a tissue sample collection study for patients at UNC who have undergone or will undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal adenocarcinoma as part of routine medical care. Purpose: To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and after ablative therapy. To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative therapy. To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the cardia. To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53, Ki67, cyclin D1, and cyclin A, will be assessed.
Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to create pictures of living tissues and has been successfully used to generate high resolution cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially available for eye and skin use, and several clinical reports on the use of OCT in the gastrointestinal tract have been published as well. The purpose of this study is to develop a high-speed noninvasive OCT probe which can be placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in the gastrointestinal tract. This is a pilot clinical research study that is designed to advance OCT technology, which may in the future be able to replace or augment endoscopic biopsies.