UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059127 |
|---|---|
| Receipt number | R000067639 |
| Scientific Title | Validity and reliability of the Japanese version of the Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0_JP) to evaluate health-related quality of life in patients with metastatic spinal tumors |
| Date of disclosure of the study information | 2025/09/20 |
| Last modified on | 2025/09/18 21:36:13 |
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Basic information
Public title
Validity and reliability of the Japanese version of the Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0_JP) to evaluate health-related quality of life in patients with metastatic spinal tumors
Acronym
Validity and reliability of the Japanese version of the Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0_JP) to evaluate health-related quality of life in patients with metastatic spinal tumors
Scientific Title
Validity and reliability of the Japanese version of the Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0_JP) to evaluate health-related quality of life in patients with metastatic spinal tumors
Scientific Title:Acronym
Validity and reliability of the Japanese version of the Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0_JP) to evaluate health-related quality of life in patients with metastatic spinal tumors
Region
| Japan |
Condition
Condition
Metastatic spinal tumors
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reliability and validity of the Japanese version of the Spinal Oncology Study Group Outcomes Questionnaire (SOSGOQ 2.0_JP)
Basic objectives2
Others
Basic objectives -Others
Verification of the reliability and validity of the questionnaire
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Test-retest reliability, Internal consistency, Validity (Discriminant, Criterion, and construct)
Key secondary outcomes
The correlation of the SOSGOQ 2.0_JP with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) and the Numeric Rating Scale (NRS) at the lesion site
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients aged 18 years or older at the time of consent and whose native language is Japanese
(2) Patients whose primary tumor has been identified through imaging or other testing and who have been diagnosed with metastatic spinal tumors
(3) Patients with symptoms due to metastatic spinal tumors who are undergoing surgery or radiation therapy
(4) Patients who have consented to participate in this study
Key exclusion criteria
(1) Patients diagnosed with dementia
(2) Patients undergoing emergency surgery
(3) Patients with poor pain control at rest
(4) Patients with brain metastases
(5) Patients with impending or pathological fractures of the lower extremities
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | YOICHI |
| Middle name | |
| Last name | KANEUCHI |
Organization
Fukushima Medical University
Division name
Orthopaedic Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
0245471111
kaneuchi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | YOICHI |
| Middle name | |
| Last name | KANEUCHI |
Organization
Fukushima Medical University
Division name
Orthopaedic Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima
TEL
+810245471276
Homepage URL
kaneuchi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical 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
Ethics Committee of Fukushima Medical University (General Ethics Committee)
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
Tel
+81245471111
irb@fmu.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
| 2025 | Year | 09 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multi-center prospective cohort observational study to validate the reliability and validity of the Japanese version of the SOSGOQ 2.0 in patients with metastatic spinal tumors. This is a non-interventional, non-invasive study with no compensation provided to participants. The study is funded by departmental research funds of the Department of Orthopaedic Surgery, Fukushima Medical University. The study results will be presented at academic conferences and published in peer-reviewed journals, and the results will also be registered in UMIN-CTR.
Management information
Registered date
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067639
