- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02075905
Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management
Descripción general del estudio
Estado
Descripción detallada
The Investigators have previously completed a validation study in which they have identified a panel of biomarkers that can predict progression of subjects with BE and no dysplasia or low-grade dysplasia to esophageal adenocarcinoma (EAC). The biomarker panel, performed by the Fitzgerald lab, included ploidy (by image cytometry), AOL (histochemistry (IHC)), p53 (IHC), cyclin A (IHC), and dysplasia. These markers have been validated and demonstrated to be highly predictive of both progression to EAC, as well as the presence of occult malignancy elsewhere in the specimen (field effect). The final panel of validated biomarkers will be used in this study to identify patients at high risk of developing EAC.
The study will recruit 100 patients across 4 sites (University of North Carolina, Case Western Reserve University, University of Cambridge, and Academic Medical Center in Amsterdam). The specific aims of this pilot study are to:
- Demonstrate that the international, multicenter team can work together,
- Define the logistics of assaying biomarkers in real time such that in the future interventional trial, results could influence clinical decision-making, and,
- Provide further data to inform a power calculation for the full trial.
Subjects enrolled in the study will complete a questionnaire gathering hypothetical willingness to be randomized to receive endoscopic treatment intervention (RFA) or surveillance endoscopy.
Biopsy samples will be obtained from all subjects and tested for all biomarkers in the panel. Results of the biomarker panel will not be communicated to sites. Subjects with low grade dysplasia will be offered the option of receiving radiofrequency ablation (RFA) as part of routine care. Subjects with low grade dysplasia who agree to RFA will receive RFA as part of routine care. Subjects with no dysplasia and subjects with low grade dysplasia who do not want to receive RFA will receive a surveillance endoscopy in 1 year as part of routine care.
The goals of this pilot study are to ascertain the proportion of subjects in the high risk arm, to demonstrate the plausibility of performing the biomarker analysis efficiently in a sizable group of patients, to demonstrate the feasibility of delivering the endoscopic intervention (RFA), to obtain 1 year pilot data regarding progression in the high risk arm for use in sample size calculations, and to document collaboration among the centers.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
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Amsterdam, Países Bajos, 1100 DD
- Academic Medical Center
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Cambridge, Reino Unido, CB2 0XZ
- University of Cambridge
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Able to read, comprehend, and complete the consent form.
- Aged 18 to 80.
- Diagnosed with at least 3 centimeters (>3cm) of Barrett's Esophagus (BE) AND no dysplasia or low grade dysplasia per review by pathologist.
Exclusion Criteria:
- Pregnant women.
- Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after EGD).
- Known bleeding disorder.
- Status post partial or complete esophageal resection.
- Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
- Prior ablative therapy of the esophagus including prior radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, and other ablation therapies. Prior endoscopic mucosal resection (EMR) is acceptable.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Barrett's Esophagus-Low Grade Dysplasia
Subjects enrolled who have Barrett's Esophagus with low grade dysplasia.
No research intervention is administered.
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Barrett's Esophagus-no dysplasia
Subjects enrolled with Barrett's Esophagus and no dysplasia.
No research intervention is administered.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Risk Stratification
Periodo de tiempo: Baseline
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This is a pilot study the main objective of which is to determine feasibility and preparation for a larger scale study.
Baseline tissue samples will be used to stratify subjects as either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results.
Biomarker panel risk stratification will be compared to data collected 1 year post enrollment regarding current pathology and ablation treatments received since enrollment.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nicholas J Shaheen, MD, MPH, UNC-Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-3843
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre El esófago de Barrett
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NinePoint MedicalTerminadoAdenocarcinoma intramucoso | Displasia asociada a Barrett'SPaíses Bajos