UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053912 |
|---|---|
| Receipt number | R000061487 |
| Scientific Title | Significance of urinary stress markers in patients undergoing surgery for gastrointestinal cancer |
| Date of disclosure of the study information | 2024/03/21 |
| Last modified on | 2024/03/20 12:12:07 |
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Basic information
Public title
Significance of urinary stress markers in patients undergoing surgery for gastrointestinal cancer
Acronym
Urinary Biopyrin Measurement in Patients with Gastrointestinal Cancer
Scientific Title
Significance of urinary stress markers in patients undergoing surgery for gastrointestinal cancer
Scientific Title:Acronym
Urinary Biopyrin Measurement in Patients with Gastrointestinal Cancer
Region
| Japan |
Condition
Condition
Patients with gastrointestinal cancer (esophageal cancer, stomach cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, biliary tract cancer) scheduled for surgery at the Department of Gastroenterology and General Surgery, Shimane University Hospital
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the utility of urinary biopirin as a biomarker for cancer diagnosis and treatment efficacy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative urinary biopyrine levels
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) Patients with gastrointestinal cancer (esophageal cancer, stomach cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, biliary tract cancer) scheduled for surgery at the Department of Gastroenterology and General Surgery, Shimane University Hospital.
2) Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria
1) Patients with psychiatric disorders (because the urinary biopyrine level is originally high)
2) Patients with hematuria (because of measurement errors)
3) Menstruating women (because of the high possibility of blood contamination in the specimen and measurement errors) 4) Patients undergoing preoperative chemotherapy (because metabolites of anticancer drugs may enter the urine and lead to exposure of the examiner)
4) Patients undergoing preoperative chemotherapy (because metabolites of anticancer drugs may enter the urine, leading to exposure of the examiner)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Taniura |
Organization
Surgery University Faculty of Medicine.
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
TEL
0853202232
taniura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Taniura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
TEL
0853202232
Homepage URL
https://rinken.shimane-u-tiken.jp/people/196
taniura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
Tel
0853202515
kenkyu@med.shimane-u.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
| 2024 | Year | 03 | Month | 21 | 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
| 2024 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061487
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
