UMIN-CTR Clinical Trial

Basic information
Public title	Disease registry for rare intractable vassular anomalies, vassular tumors and vascular malformations, RADDAR-J [1]
Acronym	Disease registry for vascular tumors and vascular malformations
Scientific Title	Disease registry for rare intractable vassular anomalies, vassular tumors and vascular malformations, RADDAR-J [1]
Scientific Title:Acronym	Disease registry, RADDAR-J [1]
Region	Japan

Condition
Condition	rare intractable vascular anomalies, vascular tumors, vascular malformtions
Classification by specialty	Medicine in general Hematology and clinical oncology Obsterics and gynecology Pediatrics Ophthalmology Dermatology Orthopedics Radiology Anesthesiology Plastic surgery Dental medicine Adult Child
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Objects are rare intractable vascular anomalies including vascular tumors and vascular malformations and it is aimed to collect these objects' cinical information in a sustained manner for a long time period and analyze natural histories and detect their prognostic factors. Further, genetic analyses will bring about their genetic backgrounds and find out and isolate the disease specific genes, additinally structuring out the disease spectrum transversely and propose a novel therapeutic approaches for such disease.
Basic objectives2	Others
Basic objectives -Others	prospective multi-centered registry research
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) patient registration principal investigator's office register the patients willing to parrticipate for the registry. Such patinets registry contiine perpetually. 2) obtaining clinical data, specimens and samples clinical data are collected to the principal investigator's office and modify and revise by the principal investigator's office. In case of collecting specimens and samples, the principal investigeto's office collect clincal data then.
Key secondary outcomes	3) genomic analysis genomic specimens and samples sent by physicina in chargewill be analysed in an researc institute.

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	registry of clinical, biomarker and genomic data
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	informed consent, appicable cases
Key exclusion criteria	1) impossible to rule out the rate and intractable vascular anomalies, vascular tumors and vascular malformations 2) miscellaneous inappropriate for th objects
Target sample size	999999999999

Research contact person
Name of lead principal investigator	1st name sadanori Middle name Last name akita
Organization	Fukuoka University
Division name	department of plastic surgery, woind repair and regeneration, school of medicine
Zip code	8140180
Address	7-45-1 Nanakuma, Jyonan-ku, Fukuoka, 8140180
TEL	+81928668250
Email	akitas@hf.rim.or.jp

Public contact
Name of contact person	1st name nobuko Middle name Last name nakashima
Organization	Fukuoka University
Division name	department of plastic surgery, woind repair and regeneration, school of medicine
Zip code	8140180
Address	7-45-1 Nanakuma, Jyonan-ku, Fukuoka, 8140180
TEL	0928011011
Homepage URL
Email	n.nakashima@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	ministry of health, Labor and walfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto Universty Ethics Committee
Address	Yoshida konoe, Sakyo-ku, Kyoto, 6068501
Tel	0757534680
Email	ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	G1203
Org. issuing International ID_1	Kyoto University
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 10 Month 29 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	2019 Year 07 Month 08 Day
Date of IRB	2019 Year 09 Month 03 Day
Anticipated trial start date	2019 Year 10 Month 02 Day
Last follow-up date	2034 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043778