UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060906 |
|---|---|
| Receipt number | R000069575 |
| Scientific Title | Explaration of the association between genetic abnormalities and clinicopathological findings in follicular lymphoma |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/12 11:44:20 |
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Basic information
Public title
Explaration of the association between genetic abnormalities and clinicopathological findings in follicular lymphoma
Acronym
Explaration of the association between genetic abnormalities and clinicopathological findings in follicular lymphoma
Scientific Title
Explaration of the association between genetic abnormalities and clinicopathological findings in follicular lymphoma
Scientific Title:Acronym
Explaration of the association between genetic abnormalities and clinicopathological findings in follicular lymphoma
Region
| Japan |
Condition
Condition
Follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify clinicopathological findings associated with genetic abnormalities in follicular lymphoma
Basic objectives2
Others
Basic objectives -Others
'Narrative objectives1' only
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Targeted sequencing will be performed using the Twist Exome 2.0 system for target region enrichment, followed by next-generation sequencing on the DNBSEQ-G400 platform. Sequence reads will be aligned to the reference genome using the "Furo" supercomputer at Nagoya University. Subsequently, variant calling will be conducted on the same system, focusing on approximately 500 genes selected primarily from those specified in the Japanese Society of Hematology's Guidelines for Genomic Testing in Hematologic Malignancies.
Fluorescence in situ hybridization (FISH) will be performed for BCL2, BCL6, MYC, and TNFRSF14. Immunohistochemistry will be conducted for CD10, CD20, BCL2, BCL6, MUM1, MIB1, CD21, CD23, CD35, alpha-SMA, kappa, lambda, CD3, PD1, and ICOS.
Morphological evaluation by light microscopy will include grading, the proportion of follicular versus diffuse architecture, presence or absence of concomitant DLBCL, marginal zone differentiation, plasmacytic differentiation, and deposition of hyalinized material in the background. Other specific findings might be additionally analyzed in the process of the evaluation.
Correlation analyses will then be performed to evaluate the relationships between these pathological findings and underlying genetic abnormalities.
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
Patients diagnosed with follicular lymphoma between January 1, 2000, and August 31, 2022, at Nagoya University Hospital or at collaborating institutions that contributed only existing samples and clinical information.
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kennosuke |
| Middle name | |
| Last name | Karube |
Organization
Graduate School of Medicine, Nagoya University
Division name
Department of Pathology and Laboratory Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Aichi, Japan
TEL
052-744-2896
karube@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kennosuke |
| Middle name | |
| Last name | Karube |
Organization
Graduate School of Medicine, Nagoya University
Division name
Department of Pathology and Laboratory Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Aichi, Japan
TEL
052-744-2896
Homepage URL
karube@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Kennosuke Karube
Funding Source
Organization
Eisai Co., Ltd.
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
Bioethics Review Committee, Nagoya University Graduate School of Medicine and Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
ethics@med.nagoya-u.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
| 2026 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
301
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-Period of Sample Collection:
From the date of approval to January 31, 2025
-Sample Storage Locations:
Department of Pathology and Laboratory Medicine, Graduate School of Medicine, Nagoya University
Department of Diagnostic Pathology, Aichi Medical University Hospital
-Human-derived Samples
All organs diagnosed as follicular lymphoma are included. Samples will be obtained from the residual portions of formalin-fixed paraffin-embedded (FFPE) blocks in which a pathological diagnosis has been made. The collected samples will be used for the evaluation of histopathological findings, immunohistochemical staining, and genetic analysis.
-Information to Be Collected
Clinicopathological information that has already been obtained for diagnostic purposes will be used. The following data will be collected: age, sex, clinical course, pathological findings, and immunohistochemical results.
Management information
Registered date
| 2026 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069575
