- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07769346
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The ACPMP Research Foundation Appendix Cancer/PMP Patient Registry is a global, patient-powered natural history study designed to systematically collect longitudinal information from individuals affected by appendix cancer and Pseudomyxoma Peritonei (PMP).
The primary aim of the Registry is to improve understanding of these rare diseases, including their characteristics, clinical course, treatment patterns, and progression over time. Information collected through the Registry will help characterize the population affected by appendix cancer and PMP, support the development of recommendations and standards of care, and provide a resource for researchers studying disease biology, treatment outcomes, and accelerate the discovery of new treatments.
Participants, caregivers, and other authorized representatives provide information through a series of online surveys that include a prompt for patients to upload pathology reports, genomic sequencing, ctDNA reports and other relevant medical documents. Retrospective and prospective data collected include sociodemographic information, medical and diagnostic history, treatments, disease progression, management of care, and quality of life. Participants are asked to return periodically to update their information, allowing changes in disease and patient experience to be evaluated over time.
The Registry also serves as a resource to support future research and clinical trial development. With appropriate review and approval, Registry data may be used by researchers conducting retrospective studies or designing prospective studies of novel treatments. The Registry may also facilitate communication with participants about research opportunities and clinical trials for which they may be eligible.
The Registry is sponsored and managed by the Appendix Cancer Pseudomyxoma Peritonei (ACPMP) Research Foundation and is hosted on the National Organization for Rare Disorders (NORD) IAMRARE® platform. The study is conducted under Institutional Review Board (IRB) oversight and follows established procedures for the collection, management, protection, and appropriate research use of participant data.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Margaret Najarian
- Número de teléfono: 704 (833) 227-6773
- Correo electrónico: patientregistry@acpmp.org
Ubicaciones de estudio
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Pennsylvania
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Springfield, Pennsylvania, Estados Unidos, 19064
- Reclutamiento
- ACPMP
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Contacto:
- Margaret Najarian Patient Registry Coordinator
- Número de teléfono: 704 (833) 227-6773
- Correo electrónico: patientregistry@acpmp.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Diagnosis of appendix cancer.
- Meets the study inclusion criteria for participation.
- Participant or, when applicable, a legally authorized representative (LAR) is able to provide informed consent and enter information into the Registry.
- A designated representative may provide retrospective information for an individual who died from appendix cancer, as permitted by the study protocol.
Exclusion Criteria:
- Individuals who do not meet the study inclusion criteria.
- Individuals for whom required informed consent cannot be obtained.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Participants with Appendix Cancer and/or Pseudomyxoma Peritonei (PMP)
Individuals diagnosed with appendix cancer and/or Pseudomyxoma Peritonei (PMP) who enroll in the ACPMP Research Foundation Appendix Cancer/PMP Patient Registry.
Participants, caregivers, or authorized representatives provide health and disease-related information through online surveys and may periodically update their information over time.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP)
Periodo de tiempo: Up to 5 years
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Characterization of the natural history and clinical course of appendix cancer and Pseudomyxoma Peritonei (PMP) using participant- and caregiver-reported data collected through the ACPMP Patient Registry.
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Up to 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disease Characteristics
Periodo de tiempo: Up to 5 years
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Disease characteristics of appendix cancer and pseudomyxoma peritonei (PMP), including disease type, extent, and other participant-reported disease characteristics.
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Up to 5 years
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Treatment History
Periodo de tiempo: Up to 5 years
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Cancer treatment history, including surgical procedures, chemotherapy, and other treatments received for appendix cancer and PMP.
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Up to 5 years
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Diagnosis
Periodo de tiempo: Up to 5 years
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Characteristics and timing of diagnosis of appendix cancer and PMP, including initial diagnosis and diagnostic findings.
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Up to 5 years
|
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Disease Progression
Periodo de tiempo: Up to 5 years
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Disease progression over time, based on participant- and caregiver-reported information regarding changes in disease status.
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Up to 5 years
|
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Management of Care
Periodo de tiempo: Up to 5 years
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Changes in management of care for appendix cancer and PMP, including treatments, procedures, and changes in care over time.
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Up to 5 years
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Signs and Symptoms
Periodo de tiempo: Up to 5 years
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Changes in signs and symptoms associated with appendix cancer and PMP over time, based on participant- and caregiver-reported data.
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Up to 5 years
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Deborah Shelton, ACPMP
- Silla de estudio: Dr. Erin P. Ward, MD, University of Utah
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- Historia Natural
- Estudio de Historia Natural
- Cáncer raro
- Registro de pacientes
- Cáncer apendicular
- Pseudomixoma peritoneal
- PMP
- LAMN
- Neoplasias malignas de la superficie peritoneal
- Appendiceal Adenocarcinoma
- Appendix Cancer
- Appendiceal Neoplasm
- Appendiceal Neoplasms
- Peritoneal Surface Malignancy
- Goblet Cell
- Signet Ring Cell
- Low-Grade Appendiceal Mucinous Neoplasm
- High-Grade Appendiceal Mucinous Neoplasm
- HAMN
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Carcinoma
- Enfermedades Peritoneales
- Neoplasias quísticas, mucinosas y serosas
- Neoplasias Abdominales
- Neoplasias Cecales
- Enfermedades del ciego
- Neoplasias Peritoneales
- Adenocarcinoma Mucinoso
- Neoplasias Apendiculares
- Pseudomixoma peritoneal
Otros números de identificación del estudio
- ACPMP-001
- NB500335 (Otro identificador: North Star Review Board)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .