- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07813585
Impact of Demography, Ethnicity, Co-morbidities and Inequalities on Outcomes in High-Grade Lymphoma Across the UKCHART Network (DECIPHER)
DECIPHER - Impact of Demography, Ethnicity, Co-morbidities and Inequalities on Outcomes in High-Grade Lymphoma Across the UKCHART Network
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Despite the provision of universal healthcare through the National Health Service (NHS), variation in treatment delivery and outcomes among patients with diffuse large B-cell lymphoma (DLBCL) persists. Previous UK population-based studies have demonstrated that socioeconomic factors and multimorbidity influence survival outcomes in aggressive lymphoma, with patients from more deprived backgrounds experiencing poorer outcomes than those from less deprived areas.
Furthermore, multimorbidity has been associated with diagnostic delay and emergency presentation, factors known to adversely affect lymphoma outcomes.
National datasets such as the National Cancer Registration and Analysis Service (NCRAS) and the Systemic Anti-Cancer Therapy (SACT) database provide valuable population-level real-world evidence and have improved understanding of lymphoma outcomes at a national level. However, these datasets often lack the detailed clinical information required to fully explore the impact of ethnicity, socioeconomic deprivation, frailty, comorbidity burden, treatment modifications, and treatment delivery on patient outcomes.
The UK Consortium for Haematology Audit, Real-world Data and Trials (UKCHART) provides a unique opportunity to address these evidence gaps. Through a network of participating NHS organisations serving a large, diverse, and geographically distributed population, UKCHART enables the collection of detailed patient-level clinical data that are not routinely available within national registries. The demographic diversity of the UKCHART population makes it particularly well suited to investigating healthcare inequalities and understanding how ethnicity, deprivation, and comorbidity influence treatment delivery and outcomes in patients with DLBCL.
This study will utilise the UKCHART network to evaluate the impact of ethnicity, socioeconomic deprivation, and comorbidity burden on the delivery of frontline chemoimmunotherapy and subsequent clinical outcomes in patients with newly diagnosed DLBCL. By generating contemporary UK real-world evidence, the study aims to identify potentially modifiable factors contributing to outcome disparities and inform future strategies to improve equity of care for patients with high-grade lymphoma.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged ≥18 years.
- Newly diagnosed DLBCL.
- Managed within participating UKCHART sites.
Exclusion Criteria:
- Transformed lymphoma.
- Insufficient linkage data.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment completion
Periodo de tiempo: Time Period between 2021-2026
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Delivered versus planned number of frontline chemoimmunotherapy cycles
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Time Period between 2021-2026
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Dose intensity reduction
Periodo de tiempo: Time Period between 2021-2026
|
Occurrence and magnitude (%) of chemotherapy dose reductions, particularly reductions >25% from planned treatment
|
Time Period between 2021-2026
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival (OS)
Periodo de tiempo: Time Period between 2021-2026
|
Measured as time from diagnosis (or treatment start, as defined in the SAP) to death from any cause
|
Time Period between 2021-2026
|
|
Progression-Free Survival (PFS)
Periodo de tiempo: Time Period between 2021-2026
|
Measured as time from diagnosis/treatment initiation to disease progression, relapse, or death.
|
Time Period between 2021-2026
|
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Stage at Diagnosis
Periodo de tiempo: Time Period between 2021-2026
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Measured using Ann Arbor stage recorded at diagnosis
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Time Period between 2021-2026
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Time to Treatment Initiation
Periodo de tiempo: Time Period between 2021-2026
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Measured as the interval between diagnosis and commencement of first-line treatment.
|
Time Period between 2021-2026
|
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026HAE151
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