UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058584 |
|---|---|
| Receipt number | R000066986 |
| Scientific Title | Evaluation for the effect of G-CSF administration when initiating R-CHOP therapy in patients with diffuse large B-cell lymphoma: Observational study using a Japanese real-world database |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/24 13:32:48 |
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Basic information
Public title
Evaluation for the efficacy and safety of G-CSF in patients with diffuse large B-cell lymphoma: Observational study
Acronym
Study to evaluate the efficacy and safety of G-CSF
Scientific Title
Evaluation for the effect of G-CSF administration when initiating R-CHOP therapy in patients with diffuse large B-cell lymphoma: Observational study using a Japanese real-world database
Scientific Title:Acronym
Database study to evaluate the efficacy and safety of G-CSF
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 confirm the effect of G-CSF administrations on the occurrence of febrile neutropenia after the first cycle of R-CHOP therapy and the change of the second cycle of R-CHOP therapy in patients with newly diagnosed diffuse large B-cell lymphoma using a Japanese real-world database.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of the incidence of febrile neutropenia
Key secondary outcomes
The change of the second cycle of R-CHOP therapy (start date/dose intensity)
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
- Hospitalized for DLBCL.
- Initiated R-CHOP therapy.
Key exclusion criteria
- G-CSF were used between hospitalization for DLBCL and initiation of R-CHOP therapy.
- Did not have follow-up period for outcomes.
- R-CHOP therapy was initiated within 30 days prior to hospitalization for DLBCL.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Akazawa |
Organization
Meiji Pharmaceutical University
Division name
Public Health and Epidemiology
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose-shi, Tokyo 204-8588, Japan
TEL
042-495-8932
makazawa@my-pharm.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Tsuchiya |
Organization
RAD-AR
Division name
Pharmacoepidemiology group mdv team
Zip code
103-0016
Address
12-7 Nihonbashi-koami, Chuo-ku, Tokyo 103-0016, Japan
TEL
03-3663-8891
Homepage URL
https://www.rad-ar.or.jp/
tsuchiya@rad-ar.or.jp
Sponsor or person
Institute
RAD-AR
Institute
Department
Personal name
Funding Source
Organization
Research Organization of Information and Systems The Institute of Statistical Mathematics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Organization of Information and Systems The Institute of Statistical Mathematics
Address
10-3, Midori-cho, Tachikawa, Tokyo 190-8562, Japan
Tel
050-5533-8513
kenkyu@list.ism.ac.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
| 2025 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study using a Medical Data Vision (MDV) database. Since the data handled is anonymous, it was determined that deliberation by the ethical committee is not necessary.
Management information
Registered date
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066986
