UMIN-CTR Clinical Trial

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
Email	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
Email	fukutaku@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043827