- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07716579
Assessment of Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment
Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Survivors of primary brain tumors treated during childhood may develop endocrine, metabolic, neurological, psychological, and cardiovascular late effects several years after completion of cancer treatment.
This prospective, single-group interventional study included individuals who had been treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years and who had survived for at least 5 years after diagnosis.
Following enrollment and informed consent, all participants were prospectively assigned, according to the study protocol, to undergo the same Study-Specific Endocrine and Metabolic Late-Effects Assessment. Participation in the study determined the standardized manner and intensity with which the protocol-defined procedures were performed; participants would not otherwise necessarily have received the same assessment package during routine clinical follow-up.
The protocol-defined assessment included review of medical history and previous cancer treatment, measurement of body weight, height, waist and hip circumference, arm span and sitting height, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers.
The study-specific assessment also included vascular evaluation by measurement of carotid intima-media thickness.When the relevant results were not already available, dual-energy X-ray absorptiometry for the assessment of bone mineral density and body composition, and pulse wave velocity assessment, were performed or arranged according to the study protocol.
Medical record data on tumor type and location, age at diagnosis, treatment modalities, date of treatment completion, current therapy, and previously identified late effects were also collected. No investigational medicinal product was administered.
The primary objective was to identify the occurrence and severity of endocrine and metabolic late effects following treatment of childhood brain tumors. Additional analyses evaluated associations between the identified late effects and tumor location, tumor type, treatment modality, age at diagnosis, and physical functioning.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ljubljana, Eslovenia, 1000
- Institute of Oncology Ljubljana
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Individuals treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years.
- Survival for at least 5 years after the diagnosis of a primary brain tumor.
- Written informed consent provided by the participant or, when applicable, by a parent or legal guardian.
Exclusion Criteria:
- Failure to meet the inclusion criteria.
- Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Study-Specific Endocrine and Metabolic Late-Effects Assessment
Participants were prospectively assigned to undergo the protocol-defined endocrine and metabolic late-effects assessment.
The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments.
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According to the study protocol, participants underwent a study-specific assessment to identify endocrine and metabolic late effects after treatment of a primary brain tumor during childhood.
The assessment included anthropometric measurements, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers.
Vascular assessment included measurement of carotid intima-media thickness.
Bone mineral density, body composition, and pulse wave velocity assessments were performed or arranged according to the protocol when the relevant results were not already available.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
Periodo de tiempo: Baseline
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Number and percentage of participants with at least one endocrine or metabolic late effect identified by the protocol-defined Study-Specific Endocrine and Metabolic Late-Effects Assessment.
Late effects were identified using medical history, clinical endocrine evaluation, anthropometric measurements, repeated blood pressure measurements, and laboratory findings, including growth-related, thyroid, gonadal, adrenal, glucose, insulin, lipid, liver, and vitamin D parameters.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number and Percentage of Participants With Endocrine or Metabolic Late Effects by Tumor and Treatment Characteristics
Periodo de tiempo: Baseline
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Number and percentage of participants with endocrine or metabolic late effects, summarized according to tumor type and location, age at diagnosis, and previous treatment characteristics, including surgery, chemotherapy, and radiotherapy.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lorna Zadravec Zaletel, MD, PhD, Institute of Oncology Ljubljana
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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 Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Enfermedades Nutricionales y Metabólicas
- Neoplasias Cerebrales
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
Otros números de identificación del estudio
- OI-LATE-BT-2023-01
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.
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