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Impact of GLP-1 Receptor Agonists on Patients With IPMN (IPMN-GLP1RA) 30

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07014709 (IPMN-GLP1RA) es un estudio observacional para NIMP (Neoplasia intraductal papilar mucinosa), NIMP, pancreática, GLP-1, Neoplasia mucinosa papilar intraductal del páncreas, Glucagon-Like Peptide-1 Receptor Agonists. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 31 de mayo de 2025 hasta completar 30 participantes. Dirigido por Hôpital Fribourgeois, se espera que finalice el 31 de octubre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 11 de junio de 2025.
Resumen
This study investigates the impact of GLP-1 receptor agonists (GLP-1 RAs) on patients with intraductal papillary mucinous neoplasms (IPMNs), a type of pancreatic cystic neoplasm that can progress to malignancy. With the increasing use of GLP-1 RAs for managing diabetes and obesity, concerns about their potential to influence pancreatic conditions, like IPMNs, have emerged. Although GLP-1 RAs are generally safe, their...Mostrar más
Descripción detallada
This is a retrospective, multicentric cohort study designed to investigate the impact of GLP-1 receptor agonists (GLP-1 RAs) on patients with intraductal papillary mucinous neoplasms (IPMNs), a subtype of pancreatic cystic neoplasms with variable but potentially significant malignant potential. IPMNs are increasingly diagnosed due to advancements in cross-sectional imaging techniques, and their management often inclu...Mostrar más
Título oficial

Impact of GLP-1 Receptor Agonists on Patients With Intraductal Papillary Mucinous Neoplasms: A Retrospective Multicentric Cohort Study

Condiciones médicas
NIMP (Neoplasia intraductal papilar mucinosa)NIMP, pancreáticaGLP-1Neoplasia mucinosa papilar intraductal del páncreasGlucagon-Like Peptide-1 Receptor Agonists
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • IPMN-GLP1RA
Número del NCT
Inicio del estudio (real)
2025-05-31
Última actualización
2025-06-11
Fecha de finalización (estimada)
2026-10-31
Inscripción (prevista)
30
Tipo de estudio
Observacional
Estado general
Aún no recluta
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Intraductal Papillary Mucinous Neoplasms
Patients eligible for this study must have a radiological diagnosis of IPMN
GLP1 receptor agonist
Patients must be under GLP1-RA treatment for ether diabetes or obesity
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Radiological changes in pancreatic cyst characteristic as described in the Kyoto 2023 Consensus
Radiological data, including data from MRI scans, will be used to monitor changes in IPMN characteristics. If only CT scans are available, they will also be evaluated, even if this is not the preferred imaging method for IPMN evaluation
during the GLP1 RA treatment
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Incidence of acute pancreatitis
The incidence of acute pancreatitis under GLP1-RA will be evaluated
during the GLP1 RA treatment
Changes in serum tumor markers, CA19-9 and CEA levels
When already available in routine analyses before and after initiation of GLP-1 RA therapy, tumor markers level will be assessed to detect any changes
during the GLP1 RA treatment
Changes in Endoscopic ultrasonography (EUS) characteristics
Evaluate the changes of morphological IPMN characteristic in endoscopic ultrasonography (EUS)
during the GLP1 RA treatment
Progression of IPMNs to high-grade dysplasia or invasive malignancy in histopathological analysis
Evaluate the progression of IPMNs to high-grade dysplasia or invasive malignancy in histopathological analysis
during the GLP1 RA treatment
Need for surgical intervention
Investigate the need for surgical intervention associated with the introduction of GLP-1 RA treatment
during the GLP1 RA treatment
Changes in IPMN surveillance protocols
Investigate the need for changes in IPMN surveillance protocols associated with GLP-1 RA use.
during the GLP1 RA treatment
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • > 18 years old
  • Radiological diagnosis of IPMN
  • Treated with GLP-1 RAs.
  • Patients must have provided prior informed consent for the use of their coded clinical data in research.

  • radiological diagnosis of IPMN is unclear,
  • no documented history of GLP-1 RAs use
  • patients did not provide signed informed consent, or have documented refusal for research.
Hôpital Fribourgeois logoHôpital Fribourgeois
  • Insel Gruppe AG, University Hospital Bern logoInsel Gruppe AG, University Hospital Bern
  • University Hospital, Geneva logoUniversity Hospital, Geneva
Contactos centrales del estudio
Contacto: Melissa Lagger, Dipl.med, +41798164051, [email protected]
1 Centros del estudio en 1 países
HFR Hopital fribourgeois, Villars-sur-Glâne, 1752, Switzerland
Melissa Lagger, Contacto, +41263062608, [email protected]
Léo Buhler, Prof., Contacto, +41263062510, [email protected]
Michel Adamina, Prof, Investigador principal