UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054261 |
|---|---|
| Receipt number | R000061953 |
| Scientific Title | Search for an optimal equation for estimating glomerular filtration rate (GFR) in Japanese patients with digestive malignancies: Considering muscle mass |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2025/10/27 18:06:50 |
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Basic information
Public title
Search for an optimal equation for estimating glomerular filtration rate (GFR) in Japanese patients with digestive malignancies: Considering muscle mass
Acronym
Search for an optimal equation for estimating glomerular filtration rate (GFR) in Japanese patients with digestive malignancies: Considering muscle mass
Scientific Title
Search for an optimal equation for estimating glomerular filtration rate (GFR) in Japanese patients with digestive malignancies: Considering muscle mass
Scientific Title:Acronym
Search for an optimal equation for estimating glomerular filtration rate (GFR) in Japanese patients with digestive malignancies: Considering muscle mass
Region
| Japan |
Condition
Condition
unresectable digestive malignancies
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To search for an estimation formula that can most accurately evaluate GFR in Japanese patients with gastrointestinal malignancies among eGFR equations.
Basic objectives2
Others
Basic objectives -Others
To search for an appropriate GFR estimation equation for Japanese patients with gastrointestinal malignancies and evaluate the influence of muscle mass on eGFR.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between inulin clearance and eGFR calculated using various estimation equations
Key secondary outcomes
Clinical characteristics of cases with significant discrepancies between inulin clearance and eCcr calculated by the CG equation
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. Over 18 years of age
2. Presence of unresectable gastrointestinal malignancies
3. Written informed consent
Key exclusion criteria
1. History of hypersensitivity to inulin.
2. Those who are taking probucol, tocopherol acetate, or vitamin preparations and are unable to take a break from taking them on the day before and on the day of inulin clearance measurement.
3. The patient is taking methyldopa orally.
4. eGFR calculated using the Japanese Society of Nephrology's estimation formula is less than 15 mL/min/1.73m2.
5. Subjects who are taking steroids and cannot stop taking them for 14 days before measuring inulin clearance.
6. Other individuals who are judged by the research director or co-researcher to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Division of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
TEL
0117161161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Kaneko |
Organization
Hokkaido University Hospital
Division name
Division of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
TEL
0117161161
Homepage URL
kaneko.shiho.s8@elms.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university hospital, Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
0117161161
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
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
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research implementation period: Until December 31, 2028
Management information
Registered date
| 2024 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061953
