UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028136 |
|---|---|
| Receipt number | R000032206 |
| Scientific Title | Spatiotemporal alteration of lipid and protein in ligamentum flavum hypertrophy of human |
| Date of disclosure of the study information | 2017/07/10 |
| Last modified on | 2024/07/12 14:31:31 |
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Basic information
Public title
Spatiotemporal alteration of lipid and protein in ligamentum flavum hypertrophy of human
Acronym
Spatiotemporal alteration of lipid and protein in ligamentum flavum hypertrophy of human
Scientific Title
Spatiotemporal alteration of lipid and protein in ligamentum flavum hypertrophy of human
Scientific Title:Acronym
Spatiotemporal alteration of lipid and protein in ligamentum flavum hypertrophy of human
Region
| Japan |
Condition
Condition
ligamentum flavum Hypertrophy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the difference or change of lipids in ligamentum flavum hypertrophy of human
Basic objectives2
Others
Basic objectives -Others
To clarify the pathology of ligamentum flavum hypertrophy of human
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of lipid and protein in ligamentum flavum of surgical patients
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
| Maneuver |
Interventions/Control_1
resection of ligamentum flavum
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1-1. surgical patients with hypertrophy ligamentum flavum
1-2. surgical patients without hypertrophy ligamentum flavum (control group)
2. with agreement of informed consent
Key exclusion criteria
1. without agreement of informed consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Yamato |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedics
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
+81-53-435-2299
yamato@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Yamato |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedics
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
+81-53-435-2299
Homepage URL
yamato@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, 431-3192, Japan
Tel
+81-53-435-2111
rinri@hama-med.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
| 2017 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
16
Results
Phosphatidylcholine (PC) and [PC (26: 0) + H] +, which were prominent in the quantitative evaluation, increased in all cases in the hypertrophic group compared to the target group, and increased 3.6 times per weight. Furthermore, the expression level of [PC (26: 0) + H] + was significantly correlated with ligament thickening (r = 0.64, P = 0.008).
Results date posted
| 2021 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Lumbar spinal canal stenosis patients were selected as the thickening group, and lumbar disc herniated patients were selected as the control group.
Participant flow
The ligamentum flavum obtained from patients with LSCS during surgery was defined as the thickening group, and the control group was defined as the ligamentum flavum obtained from patients with lumbar herniated disk. In the hypertrophic group, we performed the first lipidomics for HLF in a group of 3 patients with type II diabetes as a comorbidity.
Adverse events
None
Outcome measures
Lipids contained in 0.5 g of ligaments were extracted using the Bligh-Dyer method and separated and identified using liquid chromatography (Dionex Ultimate 3000, Thermo Fisher) / mass spectrometry (Q Exactive Orbitrap, the same company). PC (12: 0/12: 0) (Avanti Polar Lipid) was used as the internal standard.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032206
