UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051598 |
|---|---|
| Receipt number | R000058836 |
| Scientific Title | Relationship between 5-aminolevulinic acid and iron metabolism |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2026/02/09 11:42:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between 5-aminolevulinic acid and iron metabolism
Acronym
Relationship between 5-aminolevulinic acid and iron metabolism
Scientific Title
Relationship between 5-aminolevulinic acid and iron metabolism
Scientific Title:Acronym
Relationship between 5-aminolevulinic acid and iron metabolism
Region
| Japan |
Condition
Condition
Brain tumor
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will pursue iron metabolism after administration of 5-aminolevulinic acid (5-ALA).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum iron concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Taking a blood sample
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PDD-neurosurgery patients with consent for research
Key exclusion criteria
PDD-neurosurgery patients without consent for research
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Shiratori |
Organization
Ina Central Hospital
Division name
Anesthesiology
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano
TEL
0265-72-3121
ts_62475@inahp.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Shiratori |
Organization
Ina Central Hospital
Division name
Anesthesiology
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano
TEL
0265-72-3121
Homepage URL
ts_62475@inahp.jp
Sponsor or person
Institute
Ina Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ina Central Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ina Central Hospital
Address
1313-1 Koshiroukubo, Ina, Nagano
Tel
0265-72-3121
ts_62475@inahp.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
| 2023 | Year | 07 | Month | 14 | 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
| 2023 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058836
