UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062768 |
|---|---|
| Receipt number | R000071860 |
| Scientific Title | Development of a prognostic prediction model for hospitalized patients based on the integrated assessment of cachexia, sarcopenia, and malnutrition |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/09/01 17:28:42 |
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Basic information
Public title
A study of body weight, muscle status, nutritional status, and post-discharge outcomes in hospitalized patients receiving rehabilitation
Acronym
Post-Discharge Health Study
Scientific Title
Development of a prognostic prediction model for hospitalized patients based on the integrated assessment of cachexia, sarcopenia, and malnutrition
Scientific Title:Acronym
ICSM Prognosis Study
Region
| Japan |
Condition
Condition
Gastroenterological and oncological diseases; cachexia, sarcopenia, and malnutrition
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a prognostic prediction model for death, unplanned readmission, and decline in quality of life within 12 months after discharge, based on the integrated and longitudinal assessment of cachexia, sarcopenia, and malnutrition in adult hospitalized patients receiving rehabilitation in gastroenterology, gastrointestinal endoscopy, and medical oncology wards at Tokyo Women's Medical University Hospital.
Basic objectives2
Others
Basic objectives -Others
Development of a prognostic prediction model
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of death or unplanned readmission within 12 months after discharge
Key secondary outcomes
Changes in quality of life at 6 and 12 months after discharge; in-hospital changes in activities of daily living, body weight, muscle mass, muscle strength, physical function, oral function, and nutritional status; and associations of risk classifications with death and unplanned readmission.
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 admitted to the 7th floor of the First Ward at Tokyo Women's Medical University Hospital who receive care from the Departments of Gastroenterology, Gastrointestinal Endoscopy, or Medical Oncology
2) Patients who receive rehabilitation during hospitalization
3) Patients aged 18 years or older at enrollment
4) Patients who provide written informed consent, or whose legally acceptable representative provides written consent
Key exclusion criteria
1) Patients who do not provide consent for study participation
2) Patients for whom required assessments such as anthropometry, muscle strength measurement, or questionnaires are difficult to perform
3) Patients judged to be difficult to follow after discharge
4) Patients otherwise judged by the principal investigator to be inappropriate for participation
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kakehi |
Organization
Tokyo Women's Medical University
Division name
Department of Rehabilitation
Zip code
162-8666
Address
Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
kakehi.shingo@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kakehi |
Organization
Tokyo Women's Medical University
Division name
Department of Rehabilitation
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
kakehi.shingo@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Shingo Kakehi
Funding Source
Organization
Japan Society for the Promotion of Science
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
Tokyo Women's Medical University Institutional Review Board
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
Tel
0333538111
chiken.bm@twmu.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
| 2026 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective observational study will examine the associations of cachexia risk classification, sarcopenia, malnutrition, muscle mass, muscle strength, physical function, physical activity, oral function, activities of daily living, quality of life, and inflammatory markers with death, unplanned readmission, and decline in quality of life within 12 months after discharge. No new blood sampling, imaging tests, drug administration, or therapeutic intervention will be performed for research purposes.
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071860
