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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000036971
Receipt No. R000042118
Scientific Title The effect of surgical treatments for the prognosis of spinal metastases
Date of disclosure of the study information 2019/07/01
Last modified on 2020/10/13

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Basic information
Public title The effect of surgical treatments for the prognosis of spinal metastases
Acronym Registration of the surgical cases in spinal metastases
Scientific Title The effect of surgical treatments for the prognosis of spinal metastases
Scientific Title:Acronym Registration of the surgical cases in spinal metastases
Region
Japan

Condition
Condition Spinal metastases
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate activity, pain, rate of introducing or continuing chemotherapy, quality of life, and life expectancies of the patients with spinal metastases after surgery.
Basic objectives2 Others
Basic objectives -Others case registration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival time after surgical treatments
Key secondary outcomes 1. Pre-operative and post-operative activity (Performance Status, Frankel grade, Manual Muscle Test)
2. Pre-operative and post-operative pain (Numeric rating scale)
3. Pre-operative and post-operative quality of life (EQ-5D-5L)
4. Post-operative rate of introducing and re-starting chemotherapy

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients needed surgeries for the pain and paralysis by spinal metastases
Key exclusion criteria Patients diagnosed as not spinal metastatic tumors after pathological investigations
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Iwata
Organization Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Department of Preventive and Therapeutic Research for Metastatic Bone Tumor
Zip code 060-8638
Address N15 W7 Kita-ward, Sapporo, Hokkaido
TEL 011-706-5934
Email aiwata@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Iwata
Organization Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Department of Preventive and Therapeutic Research for Metastatic Bone Tumor
Zip code 060-8638
Address N15 W7 Kita-ward, Sapporo, Hokkaido
TEL 011-706-5934
Homepage URL
Email aiwata@med.hokudai.ac.jp

Sponsor
Institute Department of Preventive and Therapeutic Research for Metastatic Bone Tumor, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization Department of Preventive and Therapeutic Research for Metastatic Bone Tumor, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
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 Hokkaido University Hospital Division of Clinical Research Administration
Address N14 W5 Kita-ward, Sapporo, Hokkaido 060-8648, Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.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 07 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 Terminated
Date of protocol fixation
2019 Year 05 Month 16 Day
Date of IRB
2020 Year 10 Month 06 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2034 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design; prospective observational study
Prognosis before surgery
1.Patient's backgroud status; age, gender, present illness, diagnosis, past history
Prognostic
2.Spine Instability Score,Epidural Spinal Cord Compression Scale
3.Surgical procedure, operation time, blood loss
4.Xp, CT, MRI, bone scinti graphy, PET-CT
5.Hematological data
6.Laboratory data(Alkarine phosphatase, total bilirubin, albumin, AST/ALT, Total protein, Lactate dehydrogenase, BUN/ s-creatinin, glomerular filtration ratio, tumor marker)
7.Activity; Performance status, Manual muscle test, Frankel grade
8.Pathological diagnosis
9.Chemotherapy
10.Radiation therapy
11.Pain score; numeric rating scale
12.Support Team Assessment Schedule
13.Survival term
14.Quality of Life (EQ-5D-5L)









Management information
Registered date
2019 Year 06 Month 05 Day
Last modified on
2020 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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