UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038417 |
|---|---|
| Receipt number | R000043778 |
| Scientific Title | Disease registry for rare intractable vassular anomalies, vassular tumors and vascular malformations, RADDAR-J [1] |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2019/10/29 10:27:35 |
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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 | Obstetrics 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
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
n.nakashima@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043778
| 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 |
