Protocolo de Desarrollo y Validación de Firma para un Ensayo Epigenético en el Diagnóstico del Cáncer de Páncreas
The purpose of this research study is to test a new process for diagnosing pancreatic cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future.
Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This clinical testing protocol outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose pancreatic cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 150 subjects per cohort across 3 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort with include the following patient populations with up to 50 patients per population:
- Pancreatic cancer, NO chemotherapy. Surgical resection and/or radiation therapy
- Pancreatic cancer, WITH chemotherapy. All stages including remission
- At risk group (individuals who have chronic pancreatitis, been diagnosed with an intraductal papillary mucinous neoplasm (IPMN), have a family history of pancreatic cancer and/or have a known genetic disposition)
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jennifer Emel, MA
- Número de teléfono: 410-553-8048
- Correo electrónico: Jennifer.Emel@umm.edu
Copia de seguridad de contactos de estudio
- Nombre: Sade Bademosi
- Número de teléfono: 410-553-8188
- Correo electrónico: Sade.Bademosi@umm.edu
Ubicaciones de estudio
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Maryland
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Glen Burnie, Maryland, Estados Unidos, 21061
- University of Maryland Baltimore Washington Medical Center
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Contacto:
- Peter Olivieri, MD
- Número de teléfono: 410-553-8241
- Correo electrónico: polivieri@umm.edu
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Sub-Investigador:
- Jeffrey Marshall, MD
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Sub-Investigador:
- Harvinder Singh, MD
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Sub-Investigador:
- Agazi Gebreselassie, MD
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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
Study participants will be selected from patients being cared for across the University of Maryland Medical System
Descripción
Inclusion Criteria:
- 18 years old or older
- Patient of UMMS
- Willing and able to consent to study procedures listed in the protocol
- Ability to speak and understand English
- Has a history of pancreatic cancer of is at high risk for pancreatic cancer
Exclusion Criteria:
- Younger than 18 years old
- Patient not cared for at UMMS
- Unable to consent to study procedures listed in the protocol
- Unable to speak or understand English
- Does not have a history of pancreatic cancer or is not at high risk for pancreatic cancer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Study Population 1
This study population will consist of individuals who have a diagnosis of pancreatic cancer and have not received chemotherapy treatment for their pancreatic cancer. Individuals who have received surgical resection and/or radiation therapy for their pancreatic cancer will be included. |
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Study Population 2
This study population will consist of individuals who have a diagnosis of pancreatic cancer and have received chemotherapy treatment for their pancreatic cancer. All stages of pancreatic cancer will be included including individuals in remission. |
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Study Population 3
This study population will consist of individuals who are at high risk of developing pancreatic cancer. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Identification of tumor-associated host methylation signature
Periodo de tiempo: 5 years
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Genome-wide methylation profile of whole blood from pancreatic cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects. |
5 years
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Technology development
Periodo de tiempo: 5 years
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The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction. |
5 years
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Technology validation
Periodo de tiempo: 5 years
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The investigators will validate identified blood-based circulating methylation signatures in patients at high risk for developing pancreatic cancer. |
5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Li Y, Fan Z, Meng Y, Liu S, Zhan H. Blood-based DNA methylation signatures in cancer: A systematic review. Biochim Biophys Acta Mol Basis Dis. 2023 Jan 1;1869(1):166583. doi: 10.1016/j.bbadis.2022.166583. Epub 2022 Oct 18.
- Terp SK, Stoico MP, Dybkaer K, Pedersen IS. Early diagnosis of ovarian cancer based on methylation profiles in peripheral blood cell-free DNA: a systematic review. Clin Epigenetics. 2023 Feb 14;15(1):24. doi: 10.1186/s13148-023-01440-w.
- Ibrahim J, Peeters M, Van Camp G, Op de Beeck K. Methylation biomarkers for early cancer detection and diagnosis: Current and future perspectives. Eur J Cancer. 2023 Jan;178:91-113. doi: 10.1016/j.ejca.2022.10.015. Epub 2022 Oct 27.
- Guo Y, Yin J, Dai Y, Guan Y, Chen P, Chen Y, Huang C, Lu YJ, Zhang L, Song D. A Novel CpG Methylation Risk Indicator for Predicting Prognosis in Bladder Cancer. Front Cell Dev Biol. 2021 Sep 1;9:642650. doi: 10.3389/fcell.2021.642650. eCollection 2021.
- Xie Y, Li P, Sun D, Qi Q, Ma S, Zhao Y, Zhang S, Wang T, Wang J, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Wang C, Du L. DNA Methylation-Based Testing in Peripheral Blood Mononuclear Cells Enables Accurate and Early Detection of Colorectal Cancer. Cancer Res. 2023 Nov 1;83(21):3636-3649. doi: 10.1158/0008-5472.CAN-22-3402.
- Wang T, Li P, Qi Q, Zhang S, Xie Y, Wang J, Liu S, Ma S, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Du L, Wang C. A multiplex blood-based assay targeting DNA methylation in PBMCs enables early detection of breast cancer. Nat Commun. 2023 Aug 7;14(1):4724. doi: 10.1038/s41467-023-40389-5.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Procesos Neoplásicos
- Condiciones Patológicas, Signos y Síntomas
- Metástasis de neoplasias
- Neoplasias pancreáticas
Otros números de identificación del estudio
- HP-00118397
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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