UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033144 |
|---|---|
| Receipt number | R000037742 |
| Scientific Title | Feasibility study of clinical sequence in adult malignant lymphoma. |
| Date of disclosure of the study information | 2018/06/25 |
| Last modified on | 2025/07/13 14:50:08 |
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Basic information
Public title
Feasibility study of clinical sequence in adult malignant lymphoma.
Acronym
Study of clinical sequence in malignant lymphoma.
Scientific Title
Feasibility study of clinical sequence in adult malignant lymphoma.
Scientific Title:Acronym
Study of clinical sequence in malignant lymphoma.
Region
| Japan |
Condition
Condition
Malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the feasibility of clinical sequence in the diagnosis and treatment of malignant lymphoma.
Basic objectives2
Others
Basic objectives -Others
Confirmation of percentage of cases with identified potentially actionable findings (PAFs)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of potentially actionable findings(PAF),
used as a feedback to the attending physician
Key secondary outcomes
1) Percentage of clinically impactful findings (CIF) identified
2) Average number of days required to return analysis results to physicians in charge
3) Percentage of cases in which genome analysis is not possible and the causes
4) Percentage of cases with identified germline mutations eligible for return
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All items listed below are required.
1) Diagnosed as diffuse large B-cell lymphoma (DLBCL) in WHO classification (2016).
2) Twenty years old or higher age.
3) Tumor or non-tumor tissues are available for genome analyses.
Tumor tissue sample: a) and b)
a) biopsy sample at diagnosis (frozen tissues, cell suspension, or genome DNA)
b) Formalin fixed parafin embedded (FFPE) tissue section samples for histological analyses.
Non-tumor tissue samples: a) or b)
a) peripheral blood sample at diagnosis
b) peripheral blood sample at entry
4) Patients who filled out the informed consent forms.
Key exclusion criteria
1) Patients enrolled in another critical trials for treatment.
2) Patients who can not obtain enough amount of DNA samples for genome analyses.
3) A subject considered as an inappropriate participant for the current study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Tomita |
Organization
Fujita Health University School of Medicine
Division name
Department of Hematology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Aichi, Japan.
TEL
+81-562-93-9243
atomita@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Akinaol |
| Middle name | |
| Last name | Okamoto |
Organization
Fujita Health University School of Medicine
Division name
Department of Hematology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Aichi, Japan.
TEL
+81-562-93-9243
Homepage URL
aokamoto@fujita-hu.ac.jp
Sponsor or person
Institute
Agency for Medical Research and Development; Program for an Integrated Database of Clinical and Genomic Information; Horibe research team.
Institute
Department
Personal name
Funding Source
Organization
Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
Tel
0562932000
f-irb@fujita-hu.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
| 2018 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/cas.14552
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/cas.14552
Number of participants that the trial has enrolled
25
Results
Gene panel analyses was performed for de novo DLBCL (N=25), acute leukemia (N=25), multiple myeloma (N=25), and childhood acute leukemia (N=25), and results were returned to the attending physician after discussion by the expert committee. Of the 96 evaluable cases, 79 (82%) had PAF. In 25 cases of DLBCL, 92%, 76%, and 56% of cases yielded information useful in diagnosis, prognosis, and treatment, respectively. The median time from submission to report return was 44 days.
Results date posted
| 2025 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
De novo DLBCL (N=25), acute leukemia (N=25), multiple myeloma (N=25), and childhood acute leukemia (N=25),
Participant flow
Biopsy samples used for pathological diagnosis are submitted to the laboratory company
Adverse events
Not applicable
Outcome measures
1) Percentage of potentially actionable findings (PAF) obtained
2) Time taken from specimen submission to return of results (turn around time)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
Using the next generation sequencing, we evaluate the ratio of the adult malignant lymphoma cases with PAF (Potentially actionable findings), and evaluate the feasibility of clinical sequence in the diagnosis and treatment of malignant lymphoma.
Management information
Registered date
| 2018 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037742
