UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038467 |
|---|---|
| Receipt number | R000043827 |
| Scientific Title | Proteomic analysis for establishing a biomarker panel for the onset of Adult T-cell Leukemia (ATL) |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2019/11/01 17:42:51 |
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Basic information
Public title
Proteomic analysis for establishing a biomarker panel for the onset of Adult T-cell Leukemia (ATL)
Acronym
Proteomic analysis for establishing a biomarker panel for ATL
Scientific Title
Proteomic analysis for establishing a biomarker panel for the onset of Adult T-cell Leukemia (ATL)
Scientific Title:Acronym
Proteomic analysis for establishing a biomarker panel for ATL
Region
| Japan |
Condition
Condition
Adult T-cell Leukemia (ATL)
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Search for blood-based protein biomarkers for ATL onset, prognosis, and chemosensitivity, by comparing proteomic profiles in HTLV-1 carrier state versus ATL, ATL subtypes (acute, lymphoma, chronic, smoldering), and ATL versus remission state
Basic objectives2
Others
Basic objectives -Others
Establishment of biomarker panel for ATL
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Calculation of p-values by t-test and discrimination capacities using AUC index, and setting of discrimination boundaries in multi-protein comparisons using machine learning algorithms, and ranking proteins based on AUC and significant values to detect candidate biomarker panel for ATL
Key secondary outcomes
Development a proteomic profile for ATL patients categorized according to ATL subtype (acute, chronic, smoldering, lymphoma) to search for ATL prognostic biomarkers; Development of a proteomic profile for ATL versus ATL in remission to search for ATL chemosensitivity biomarkers
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
Cryopreserved plasma samples in the Okinawa HTLV-1/ATL Biobank (with consent for biological sample storage and use for future research) are used for this study. These samples were obtained from patients recruited from the following research projects: Establishment of the Okinawa HTLV-1/ATL Biobank, with University of the Ryukyus clinical ethics review no. 777, and Clinical Application of the Minute Residual Disease (MRD) in high-grade ATL patients, with University of the Ryukyus clinical ethics review no. 478
Key exclusion criteria
Participants withdrawing consent through opt-out forms available online at the homepage of the Laboratory of Hematoimmunology are excluded
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Fukushima |
Organization
University of the Ryukyus
Division name
School of Health Sciences, Faculty of Medicine, Laboratory of Hematoimmunology
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa, Japan
TEL
+81-98-895-1276
fukutaku@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Fukushima |
Organization
University of the Ryukyus
Division name
School of Health Sciences, Faculty of Medicine, Laboratory of Hematoimmunology
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa, Japan
TEL
+81-98-895-3331
Homepage URL
fukutaku@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
NEC Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus Clinical Research Ethics Review Board
Address
207 Uehara, Nishihara, Okinawa, Japan 903-0215
Tel
+81-98-895-8016
knknkyu@to.jim.u-ryukyu.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
| 2020 | Year | 03 | Month | 30 | 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
85
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
t-test, AUC index, and stepwise selection methods and evaluation of distinction performance by simple models (linear discriminant analyses, logistic regression, etc.) and machine learning methods (decision tree, neural network, support vector machine, etc. We conduct survival analysis by Kaplan-Meier method and conduct two comparison between groups by log-rank test.
Management information
Registered date
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2019 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043827
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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