UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050495 |
|---|---|
| Receipt number | R000057220 |
| Scientific Title | Monitoring study with electronic patient-reported outcome for advanced soft tissue sarcoma case during the administration of anti-tumoral drugs -JMOG066- |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2025/03/13 22:44:37 |
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Basic information
Public title
Monitoring study with electronic patient-reported outcome for advanced soft tissue sarcoma case during the administration of anti-tumoral drugs -JMOG066-
Acronym
ePRO monitoring for advanced soft tissue sarcoma undergoing anti-tumoral drugs
Scientific Title
Monitoring study with electronic patient-reported outcome for advanced soft tissue sarcoma case during the administration of anti-tumoral drugs -JMOG066-
Scientific Title:Acronym
ePRO monitoring for advanced soft tissue sarcoma undergoing anti-tumoral drugs
Region
| Japan |
Condition
Condition
advanced soft tissue sarcoma
Classification by specialty
| Hematology and clinical oncology | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify symptoms and cut-off points, and to develop the predictive model for early detection of treatment discontinuance, quality of life decrease, disease progression and death
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to treatment failure
Key secondary outcomes
overall survival, progression free survival, patient compliance in completing ePRO
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
1) Patients undergoing or scheduled to undergo second or subsequent drug therapy for metastatic or unresectable advanced soft tissue sarcoma
2) Patients who have given their consent to participate in the study via electronic manner
3) Those age 20 years or older at the time the consent is obtained
4) Patients with a histopathological diagnosis of soft tissue sarcoma at any of the following: primary, metastatic, or recurrent site
5) The primary lesion is clinically or radiologically determined to be originated from extremity or trunk wall
Key exclusion criteria
1) Patients who have difficulty in answering ePRO due to either dementia, psychiatric disorder, or others
2) Patients that the principal investigator judged incorporation into research is inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Nishisho |
Organization
Tokushima University
Division name
Department of Orthopedics
Zip code
770-8503
Address
3-18-15 Kuramoto, Tokushima, Tokushima, 770-8503, Japan
TEL
0886337240
tnishisho@gmail.com
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Toki |
Organization
Tokushima University
Division name
Department of Orthopedics
Zip code
770-8503
Address
3-18-15 Kuramoto, Tokushima, Tokushima, 770-8503, Japan
TEL
0886337240
Homepage URL
toki830926@gmail.com
Sponsor or person
Institute
Japanese Musculoskeletal Oncology Group
Institute
Department
Personal name
Funding Source
Organization
MEXT (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima, Tokushima
Tel
0886339294
awachiken@tokushima-u.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
| 2023 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
The purpose of this study is to identify symptoms and questions of significance to be assessed by ePRO monitoring and their thresholds in patients with soft tissue sarcoma undergoing drug therapy in Japan, and to develop the predictive model for early detection of treatment discontinuation, quality of life decrease, disease progression and death. We will recruit subjects in treatment and collect clinical information, ePRO monitoring data, and QoL questionnaire results. Statistical analysis, including exploratory subgroup analysis, will be performed with a primary endpoint of time to treatment failure and secondary endpoints of overall survival, progression-free survival, and health-related QoL. In the future, an automated program will be required to facilitate appropriate responses to the monitoring results. Based on the fundamental information obtained in this study, algorithms will be created and robotic process automation will be developed, and if possible, machine learning and artificial intelligence will be incorporated here.
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057220
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/03/13 | JMOG066研究計画書_240626.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/03/13 | CRF④ _ver.1.1.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/03/13 | CRF②_J0001_確認済.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/57220
