UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037774 |
|---|---|
| Receipt number | R000042670 |
| Scientific Title | A prospective study of pediatric hereditary hematological disorders |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2021/02/22 06:42:51 |
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Basic information
Public title
A prospective study of pediatric hereditary hematological disorders
Acronym
A prospective study of pediatric hereditary hematological disorders
Scientific Title
A prospective study of pediatric hereditary hematological disorders
Scientific Title:Acronym
A prospective study of pediatric hereditary hematological disorders
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Pediatric hereditary hematological disorders
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to make accurate diagnoses of pediatric hereditary hematological disorders using morphological, biochemical, and genetic tests.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to collect patient clinical information and laboratory information to promote clinical research.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of patients enrolled in this research.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under 40 years old who are diagnosed or suspected with disease below; Fanconi anemia, Diamond-Blackfan anemia, Dyskeratosis congenita, Congenital sideroblastic anemia, Severe congenital neutropenia, Congenital dyserythropoietic anemia, Congenital amegakaryocyte thrombocytopenia, Congenital thrombocytopenia, Congenital hemolytic anemia, unclassified inherited hematological disorders, primary immunodeficiencies
Key exclusion criteria
Patients who don't meet the inclusion criteria
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Nagoya university graduate school of medicine
Division name
Department of pediatrics
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
+81-52-744-2294
ytakaha@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Muramatsu |
Organization
Nagoya university graduate school of medicine
Division name
Department of pediatrics
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
+81-52-744-2294
Homepage URL
hideki-muramatsu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology
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
Ethics Committee of Nagoya university graduate school of medicine
Address
65, Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
Tel
+81-52-744-2111
ethics@med.nagoya-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 | 09 | 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
| 2019 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinidal information of the patients, such as age, sex, clinical history, family history, abnormal physical findings, result of blood tests, results of genetic tests, information about transfusion, and current treatment are registerd. Clinical course, treatment, outcome, complications, and other clinical information at 1, 2, 5, and 10 years after enrollment are registerd.
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042670
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/09/13 | 共同研究者一覧_ver14.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
