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 2021/01/14 09:08:24

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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

Email

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


Email

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

Email

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

Preinitiation

Date of protocol fixation

2017 Year 06 Month 29 Day

Date of IRB


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


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 07 Day

Last modified on

2021 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032206


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name