UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036971 |
|---|---|
| Receipt number | 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 13:03:33 |
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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
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
aiwata@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Preventive and Therapeutic Research for Metastatic Bone Tumor, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042118
