UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063113 |
|---|---|
| Receipt number | R000072250 |
| Scientific Title | Evaluation of the Long-Term Course of Physical Factors Following Esophageal Cancer Surgery and Their Relationship to Prognosis |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 12:16:48 |
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Basic information
Public title
Evaluation of the Long-Term Course of Physical Factors Following Esophageal Cancer Surgery and Their Relationship to Prognosis
Acronym
Evaluation of the Long-Term Course of Physical Factors Following Esophageal Cancer Surgery and Their Relationship to Prognosis
Scientific Title
Evaluation of the Long-Term Course of Physical Factors Following Esophageal Cancer Surgery and Their Relationship to Prognosis
Scientific Title:Acronym
Evaluation of the Long-Term Course of Physical Factors Following Esophageal Cancer Surgery and Their Relationship to Prognosis
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate changes in body composition over time and their impact on prognosis in patients who have undergone near-total esophagectomy.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate the long-term changes in body composition (body fat, skeletal muscle, and cytoplasm) in patients who have undergone subtotal esophagectomy, assessing these parameters preoperatively and at 1, 3, 6, and 12 months postoperatively. It also aims to identify factors associated with these long-term changes in body composition and their impact on prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long-term changes in various body composition parameters (body fat percentage, cytoplasm, skeletal muscle mass by region, body weight, etc.) following esophageal cancer surgery
The impact of various body composition parameters following esophageal cancer surgery on prognosis (overall survival, progression-free survival)
Key secondary outcomes
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. Individuals who have undergone subtotal esophagectomy
2. Individuals diagnosed with esophageal cancer
3. Individuals who have provided consent to participate in this study by signing a consent form
4. Individuals 18 years of age or older
Key exclusion criteria
Patients judged inappropriate by their physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yagi |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Department of hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.
TEL
0534352767
yagi5922@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sumika |
| Middle name | |
| Last name | Osa |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Department of hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.
TEL
0534352767
Homepage URL
osa.su@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.
Tel
0534352111
rinri@hama-med.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 | 30 | 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
0
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
Main results already published
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Data to Be Collected]
Subject Background: Name, age, gender, diagnosis, surgical procedure, medical history, lifestyle history, history of adverse events, concomitant medications, length of hospital stay, postoperative complications, performance status, post-discharge outcomes, number and types of medications taken, etc.
Physical Findings: Height, weight, body surface area, BMI, blood pressure, pulse, body temperature
Laboratory Tests: Hematological tests (white blood cell count, hemoglobin level, platelet count, neutrophil count, lymphocyte count, etc.), biochemical tests (total protein, AST, ALT, ALP, total bilirubin, albumin, CRP, BUN, creatinine, eGFR, cystatin-C, blood glucose, HbA1c, electrolytes, etc.)
Body Composition (body weight, BMI, skeletal muscle mass, skeletal muscle mass index, body fat mass, phase angle, grip strength, etc.)
Treatment Outcomes (duration of treatment, overall survival, progression-free survival, duration of treatment success, best response, etc.)
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072250
