UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020756 |
|---|---|
| Receipt number | R000023953 |
| Scientific Title | Analysis of 1-methyladenosine for a biomarker in patients with diffuse large B-cell lymphoma. |
| Date of disclosure of the study information | 2016/01/28 |
| Last modified on | 2022/08/02 09:13:47 |
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Basic information
Public title
Analysis of 1-methyladenosine for a biomarker in patients with diffuse large B-cell lymphoma.
Acronym
m1A in DLBCL
Scientific Title
Analysis of 1-methyladenosine for a biomarker in patients with diffuse large B-cell lymphoma.
Scientific Title:Acronym
m1A in DLBCL
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
We analyse plasma 1-methyladenosine(m1A) and analyze correlation between m1A concentration and prognosis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation of plasma m1A concentration and curative effect after chemotherapy
Key secondary outcomes
correlation of urinary m1A concentration and curative effect after chemotherapy
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
DLBCL cases who are treated by R-CHOP or R-THP-COP chemotherapy in Kanazawa Medical University.
Key exclusion criteria
DLBCL cases who are treated by other chemotherapy regimen.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasufumi |
| Middle name | |
| Last name | Masaki |
Organization
Kanazawa Medical University
Division name
Division of Hematology and Immunology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-3511
yasum@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasufumi |
| Middle name | |
| Last name | Masaki |
Organization
Kanazawa Medical University
Division name
Division of Hematology and Immunology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-3511
Homepage URL
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Shizuoka
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa Medical University
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
Tel
076-286-3511
tiken@kanazawa-med.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
金沢医科大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 28 | 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
16
Results
Under analysis
Results date posted
| 2020 | Year | 02 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
considering about significance of the publication, because significant difference is little for a result.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
We will measure plasma and urinary m1A concentration of before , day1, day2, day3, day22, and day 43 of R-CHOP or R-THP-COP chemotherapy in patients with DLBCL, and will analyze correlation with curative effect.
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
