UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052029 |
|---|---|
| Receipt number | R000059387 |
| Scientific Title | Prospective study of changes in quality of life before and after interventional radiology treatment |
| Date of disclosure of the study information | 2023/09/10 |
| Last modified on | 2024/02/28 08:38:42 |
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Basic information
Public title
Prospective study of changes in quality of life before and after interventional radiology treatment
Acronym
Changes in quality of life (QOL) before and after interventional radiology treatment
Scientific Title
Prospective study of changes in quality of life before and after interventional radiology treatment
Scientific Title:Acronym
QOL changes before and after IR treatment
Region
| Japan |
Condition
Condition
Disease groups indicated for treatment with IR
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
No studies in Japan have evaluated the quality of life (QOL) of patients treated with IR.
Therefore, in this study, we will evaluate the QOL of patients who received various IR treatments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in quality of life before and after IR treatment
Key secondary outcomes
Therapeutic efficacy for each IR treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform IR
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
Patients treated with IR
Key exclusion criteria
Patients under 18 years old
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Kochi university
Division name
Department of Diagnostic and Interventional Radiology
Zip code
783-8505
Address
Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL
0888802367
t-matsu@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Kochi University
Division name
Department of Diagnostic and Interventional Radiology
Zip code
783-8505
Address
Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL
0888802367
Homepage URL
t-matsu@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Tomohiro Matsumoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi university
Address
Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
Tel
0888802367
t-matsu@kochi-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
高知大学医学部附属病院（高知県）
高知医療センター（高知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 10 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059387
