UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of alteration of proteins in ANCA-associated vasculitis
Acronym	Alteration of proteins in ANCA-associated vasculitis
Scientific Title	Analysis of post-translational modification in ANCA-associated vasculitis
Scientific Title:Acronym	Post-translational modification in ANCA-associated vasculitis
Region	Japan

Condition
Condition	microscopic polyangiitis, granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, the other diseases in vascular syndrome, the other collagen diseases, infection, hearlthy individuals
Classification by specialty	Hematology and clinical oncology Nephrology Clinical immunology Infectious disease Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify specific post-translational modification of proteins in ANCA-associated vasculitis (AAV) and elucidate the role of the modification in the pathophysiology of AAV.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	mass spectrometry
Key secondary outcomes	2-dimensional western blotting, ELISA

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	Patients and healthy indivisuals who were diagnosed as with the target diseases and as in healthy status (without collagen diseases), respectively, in St. Marianna University Hospital and Comfort Yokohama Clinic. Healthy individuals who work as staffs in St. Marianna University, St. Marianna University Hospital, and Comfort Yokohama Clinic.
Key exclusion criteria	Patients who are inappropriate for blood examination, i.e., moderate to severe anemia.
Target sample size	900

Research contact person
Name of lead principal investigator	1st name Manae Middle name Suzuki Last name Kurokawa
Organization	St. Marianna University Graduate School of Medicine
Division name	Disease Biomarker Analysis and Molecular Regulation
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL	81-44-977-8111
Email	manae@marianna-u.ac.jp

Public contact
Name of contact person	1st name Manae Middle name Suzuki Last name Kurokawa
Organization	St. Marianna University School of Medicine
Division name	Disease Biomarker Analysis and Molecular Regulation
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL	81-44-977-8111
Homepage URL
Email	manae@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel	81-44-977-8111
Email	k-sienbu.mail@marianna-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	2019 Year 04 Month 01 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
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	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 20 Day
Date of IRB	2018 Year 02 Month 09 Day
Anticipated trial start date	2018 Year 02 Month 09 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We are analyzing post-translational modification of neutrophils and sera from the patients with target diseases and healthy individuals.

Management information
Registered date	2019 Year 03 Month 21 Day
Last modified on	2020 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041264