- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adults aged ≥18 years.
- Newly diagnosed DLBCL.
- Managed within participating UKCHART sites.
Exclusion Criteria:
- Transformed lymphoma.
- Insufficient linkage data.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment completion
Délai: Time Period between 2021-2026
|
Delivered versus planned number of frontline chemoimmunotherapy cycles
|
Time Period between 2021-2026
|
|
Dose intensity reduction
Délai: Time Period between 2021-2026
|
Occurrence and magnitude (%) of chemotherapy dose reductions, particularly reductions >25% from planned treatment
|
Time Period between 2021-2026
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: 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)
Délai: Time Period between 2021-2026
|
Measured as time from diagnosis/treatment initiation to disease progression, relapse, or death.
|
Time Period between 2021-2026
|
|
Stage at Diagnosis
Délai: Time Period between 2021-2026
|
Measured using Ann Arbor stage recorded at diagnosis
|
Time Period between 2021-2026
|
|
Time to Treatment Initiation
Délai: Time Period between 2021-2026
|
Measured as the interval between diagnosis and commencement of first-line treatment.
|
Time Period between 2021-2026
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026HAE151
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