UMIN-CTR Clinical Trial

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