UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057490 |
|---|---|
| Receipt number | R000065692 |
| Scientific Title | Physician-led Research for Early Screening & Clinical Investigation for Early Novel Treatment |
| Date of disclosure of the study information | 2025/04/06 |
| Last modified on | 2026/03/16 16:53:37 |
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Basic information
Public title
Physician-led Research for Early Screening & Clinical Investigation for Early Novel Treatment
Acronym
Physician-led Research for Early Screening & Clinical Investigation for Early Novel Treatment
Scientific Title
Physician-led Research for Early Screening & Clinical Investigation for Early Novel Treatment
Scientific Title:Acronym
Physician-led Research for Early Screening & Clinical Investigation for Early Novel Treatment
Region
| Japan |
Condition
Condition
People with subjective symptoms.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct quality of life surveys to identify subjective symptoms, leading to early diagnosis, early therapeutic intervention and reduced risk of developing complications.
Basic objectives2
Others
Basic objectives -Others
Relationship between quality of life questionnaires and physicians' clinical findings
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of life questionnaire
Key secondary outcomes
(Secondary outcomes)
The reality of subjective symptoms and medical visit records
Relationship between the timing of therapeutic intervention and symptoms
(Safety evaluation)
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
Subjects who have given verbal consent.
Subjects who are suffering from any disease and have been judged by a doctor to require treatment, or who have any subjective symptoms and are suspected by a doctor to be suffering from a disease.
Key exclusion criteria
Subjects who are judged to be unsuitable as subjects by the investigator or the sub investigator.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshimitsu |
| Middle name | |
| Last name | Yamasaki |
Organization
Osaka Nishiumeda Clinic
Division name
medical department
Zip code
530-0001
Address
Maruito Nishi-Umeda Building 3F 3-3-45 Umeda, Kita-ku, Osaka
TEL
06-4797-5660
yamasaki@taifukukai.jp
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Kitamura |
Organization
Osaka Nishiumeda Clinic
Division name
Clinical Trial Center
Zip code
530-0001
Address
Maruito Nishi-Umeda Building 3F 3-3-45 Umeda, Kita-ku, Osaka
TEL
06-4797-5660
Homepage URL
crc@ml.taifukukai.jp
Sponsor or person
Institute
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Taifukukai, Tokyo Shinjuku Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Shinjuku Clinic Ethical Review Board
Address
SIL Shinjuku 5F, 2-46-3, Kabukicho, Shinjuku-ku, Tokyo,Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
大阪西梅田クリニック
東京新宿クリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 06 | 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
93
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questions related to quality of life and questions related to health care visits.Prospective studies to be conducted
Management information
Registered date
| 2025 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065692
