UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062924 |
|---|---|
| Receipt number | R000072012 |
| Scientific Title | Comprehensive geriatric assessment before treatment in older patients with diffuse large B-cell lymphoma: a prospective study on treatment completion and optimization of geriatric screening |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 18:26:25 |
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Basic information
Public title
A study on pre-treatment assessment and treatment outcomes in older patients with diffuse large B-cell lymphoma
Acronym
GA-DLBCL study
Scientific Title
Comprehensive geriatric assessment before treatment in older patients with diffuse large B-cell lymphoma: a prospective study on treatment completion and optimization of geriatric screening
Scientific Title:Acronym
GA-DLBCL study
Region
| Japan |
Condition
Condition
Diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the predictive performance of existing geriatric assessment and prognostic indices for treatment completion in older patients (75 years or older) with DLBCL receiving curative-intent first-line therapy, and to explore whether social determinants of health (availability of social support, transportation access, nutritional status, medication management, and disease-related functional decline) provide additional predictive value beyond existing indices.
Basic objectives2
Others
Basic objectives -Others
Validation of predictive performance and exploration of social determinants of health
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment completion: completion of the pre-specified first-line treatment plan (planned number of cycles and regimen) in patients whose attending physician documented a curative treatment intent before initiation. Dose reduction is permitted.
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
| 75 | years-old | <= |
Age-upper limit
| 130 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Histologically confirmed DLBCL aged 75 years or older (main analysis) or 65-74 years with pre-treatment geriatric assessment (exploratory)
- Pre-treatment geriatric assessment completed before curative-intent first-line therapy
- Written informed consent obtained
Key exclusion criteria
- Primary CNS lymphoma
- High-grade B-cell lymphoma (MYC/BCL2 rearrangement)
- Insufficient pre-treatment information
- Patient refusal
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Sakai |
Organization
Asahikawa Red Cross Hospital
Division name
Department of Hematology and Oncology
Zip code
070-8530
Address
1-1 Akebono-Cho, Asahikawa, Hokkaido, Japan
TEL
0166-22-8111
to-sa0627@asahikawa-rch.gr.jp
Public contact
Name of contact person
| 1st name | Sakai |
| Middle name | |
| Last name | Toshiro |
Organization
Asahikawa Red Cross Hospital
Division name
Department of Hematology and Oncology
Zip code
070-8530
Address
1-1 Akebono-Cho, Asahikawa, Hokkaido, Japan
TEL
0166-22-8111
Homepage URL
to-sa0627@asahikawa-rch.gr.jp
Sponsor or person
Institute
Asahikawa Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funded (no external funding)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Asahikawa Red Cross Hospital
Address
1-1 Akebono-Cho, Asahikawa, Hokkaido, Japan
Tel
0166-22-8111
soumu@asahikawa-rch.gr.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. Pre-treatment geriatric assessment is conducted using a patient/family-completed questionnaire application and clinician-based evaluation. Treatment details, adverse events, and outcomes are collected from medical records. The primary endpoint is treatment completion (completion of the planned first-line treatment cycles with curative intent). IRB approval: No. 202652-2, Asahikawa Red Cross Hospital IRB, August 25, 2026.
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072012
