UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050530 |
|---|---|
| Receipt number | R000057517 |
| Scientific Title | Overall survival and cause of death in Japanese patients with chronic lymphocytic leukemia |
| Date of disclosure of the study information | 2023/03/09 |
| Last modified on | 2025/02/19 18:10:30 |
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Basic information
Public title
Overall survival and cause of death in Japanese patients with chronic lymphocytic leukemia
Acronym
Overall survival and cause of death in Japanese patients with chronic lymphocytic leukemia
Scientific Title
Overall survival and cause of death in Japanese patients with chronic lymphocytic leukemia
Scientific Title:Acronym
Overall survival and cause of death in Japanese patients with chronic lymphocytic leukemia
Region
| Japan |
Condition
Condition
Chronic lymphocytic leukemia
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary objective of this study is to describe the survivals and primary causes of deaths in CLL patients in real-world clinical practice in Japan.
Basic objectives2
Others
Basic objectives -Others
The Secondary objectives of the study are to identify the clinical characteristics and comorbidities diagnosed prior to or simultaneously with CLL diagnosis of patients and how these affected their cause of deaths or survival.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify survival and cause of death of CLL in Japanese real clinical practice. The causes of death are classified into four categories: 1. Progressive CLL of CLL, 2. Infection, 3. Other cancers, and 4. Comorbid health condition (in the absence of progression of CLL), of which 1, 2, and 3 are considered as CLL-related causes of death for this analysis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive CLL patients diagnosed at Kameda Medical Center, Hiroshima Red-Cross Hospital and Atomic Bomb Survivor Hospital, from 2005 to 2022.
Key exclusion criteria
Exclusion criteria of this study include human immunodeficiency virus infection and end stage solid cancer at diagnosis patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Matsue |
Organization
Kameda Medical Center
Division name
Division of Hematology/Oncology
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture
TEL
+81-04-7092-2211
koseimatsue@gmail.com
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Matsue |
Organization
Kameda Medical Center
Division name
Division of Hematology/Oncology
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture
TEL
+81-04-7092-2211
Homepage URL
koseimatsue@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center, Research Ethics Committee
Address
929 Higashi-cho,Kamogawa City,Chiba Prefecture,Japan 296-8602
Tel
04-7092-2211
clinical_research@kameda.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
亀田総合病院、広島赤十字・原爆病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/cam4.70613
Number of participants that the trial has enrolled
121
Results
Our study showed that CLL itself was the leading COD, and comorbidity burden was associated with non-CLL-specific deaths. This highlights the importance of better disease control and effective management of comorbidities.
Results date posted
| 2025 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 69 years, with 47.9% having at least one comorbidity listed in the Charlson Comorbidity Index (CCI), and 12.4% were multimorbid.
Participant flow
We retrospectively analyzed patients with CLL/small lymphocytic leukemia (SLL) who were diagnosed between 1995 and 2022 at Kameda Medical Center and Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital and followed up at least once since 2005.
Adverse events
NA
Outcome measures
With a median follow-up of 74 months, the 5-and 10-year overall survival rates were 80.6% and 60.1%, respectively. Among the 44 deaths observed, CLL progression was the leading COD (38.6%), which together with infections and other malignancies accounted for nearly 80%. Patients with higher CCI risk categories had significantly higher 5-year all-cause mortality and non-CLL specific mortality compared to those without, whereas CLL-specific mortality was not influenced.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data for this study will be extracted from all patients diagnosed with CLL at Kameda General Hospital and Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital over a 18-year period from 2005 to 2022, including age, sex, complications, clinical laboratory values, clinical stage, treatment, and prognosis, to determine factors that influenced patient outcomes and treatment.
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057517
