UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042657 |
|---|---|
| Receipt number | R000048674 |
| Scientific Title | Macular Microvascular Changes in Children with Transfusion Defendant Beta- Thalassemia |
| Date of disclosure of the study information | 2020/12/04 |
| Last modified on | 2020/12/04 21:15:12 |
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Basic information
Public title
Macular Microvascular Changes in Children with Transfusion Defendant Beta- Thalassemia
Acronym
OCT in TDT
Scientific Title
Macular Microvascular Changes in Children with Transfusion Defendant Beta- Thalassemia
Scientific Title:Acronym
OCT in TDT
Region
| Africa |
Condition
Condition
ophthalmology and pediatric hematology
Classification by specialty
| Pediatrics | Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effect of serum ferritin on retinal vasculature
Basic objectives2
Others
Basic objectives -Others
effect of serum ferritin level on retinal microvasculature
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DCP are mostly affected by ferritin level
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
| 8 | years-old | < |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
transfusion dependant thalassemia
Key exclusion criteria
- other systemic chronic disease
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Ismail |
| Middle name | Ahmed |
| Last name | Omar |
Organization
Minia university Hospital
Division name
ophthalmology
Zip code
61111
Address
EGYPT -minia city
TEL
+201002554116
ismail.omar@mu.edu.eg
Public contact
Name of contact person
| 1st name | ismail |
| Middle name | |
| Last name | Omar |
Organization
minia university
Division name
ophthalmology
Zip code
61111
Address
Egypt- Minia
TEL
+201002554116
Homepage URL
ismail.omar@mu.edu.eg
Sponsor or person
Institute
Minia university hospital
Institute
Department
Personal name
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
Minia university Hospita
Address
Egypt
Tel
+201002554116
ismail.oar@mu.edu.eg
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 | 12 | Month | 04 | 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
52
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
control group and study groups to study retinal microvasculature changes
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048674
