- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adults aged ≥18 years.
- Newly diagnosed DLBCL.
- Managed within participating UKCHART sites.
Exclusion Criteria:
- Transformed lymphoma.
- Insufficient linkage data.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment completion
Tidsramme: Time Period between 2021-2026
|
Delivered versus planned number of frontline chemoimmunotherapy cycles
|
Time Period between 2021-2026
|
|
Dose intensity reduction
Tidsramme: Time Period between 2021-2026
|
Occurrence and magnitude (%) of chemotherapy dose reductions, particularly reductions >25% from planned treatment
|
Time Period between 2021-2026
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Time Period between 2021-2026
|
Measured using Ann Arbor stage recorded at diagnosis
|
Time Period between 2021-2026
|
|
Time to Treatment Initiation
Tidsramme: Time Period between 2021-2026
|
Measured as the interval between diagnosis and commencement of first-line treatment.
|
Time Period between 2021-2026
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026HAE151
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