- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adults aged ≥18 years.
- Newly diagnosed DLBCL.
- Managed within participating UKCHART sites.
Exclusion Criteria:
- Transformed lymphoma.
- Insufficient linkage data.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment completion
기간: Time Period between 2021-2026
|
Delivered versus planned number of frontline chemoimmunotherapy cycles
|
Time Period between 2021-2026
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Dose intensity reduction
기간: Time Period between 2021-2026
|
Occurrence and magnitude (%) of chemotherapy dose reductions, particularly reductions >25% from planned treatment
|
Time Period between 2021-2026
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: 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)
기간: 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
기간: Time Period between 2021-2026
|
Measured using Ann Arbor stage recorded at diagnosis
|
Time Period between 2021-2026
|
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Time to Treatment Initiation
기간: Time Period between 2021-2026
|
Measured as the interval between diagnosis and commencement of first-line treatment.
|
Time Period between 2021-2026
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .