UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061260 |
|---|---|
| Receipt number | R000070100 |
| Scientific Title | Prospective and retrospective observational study to identify predictors of quality of life deterioration following cancer pharmacotherapy using geriatric assessment, body composition, and aging-related biomarkers in patients with gastrointestinal cancer |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/14 18:59:30 |
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Basic information
Public title
Observational study to identify predictors of quality of life deterioration following cancer pharmacotherapy in patients with gastrointestinal cancer
Acronym
QOL-PREDICT-GI
Scientific Title
Prospective and retrospective observational study to identify predictors of quality of life deterioration following cancer pharmacotherapy using geriatric assessment, body composition, and aging-related biomarkers in patients with gastrointestinal cancer
Scientific Title:Acronym
QOL-PREDICT-GI Study
Region
| Japan |
Condition
Condition
Gastrointestinal cancers (including gastric cancer, colorectal cancer, pancreatic cancer, and biliary tract cancer)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify predictors of quality of life deterioration following cancer pharmacotherapy in patients with gastrointestinal cancer by using pre-treatment assessments, including geriatric assessment, body composition analysis, and aging-related blood biomarkers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the presence or absence of deterioration in quality of life from baseline to 3 months after initiation of cancer pharmacotherapy.
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
Patients who meet all of the following criteria will be included:
1.Diagnosed with gastrointestinal cancer (esophageal, gastric, colorectal, hepatic, biliary tract, or pancreatic cancer)
2.Scheduled to initiate cancer pharmacotherapy
3.Provided written informed consent for participation in this study (informed consent will be obtained as described in Section 7.1)
4.Aged 18 years or older
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1.Patients from whom written informed consent could not be obtained (for the retrospective chart review, patients who have expressed refusal for the use of their information in this study, either by themselves or via a proxy)
2.Patients deemed inappropriate for inclusion in the study by the treating physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Sato |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Department of Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
hikaru@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Sato |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Department of Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
Homepage URL
hikaru@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-shi, Shizuoka, Japan
Tel
053-435-2111
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 | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070100
