UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032392 |
|---|---|
| Receipt number | R000036194 |
| Scientific Title | Study of correlation between in vivo oxidative stress resistance parameters of the peripheral blood by biochemical test data and the multimodal homeostasis evaluation system in the gastrointestinal disease patients (Inflammatory bowel disease, pancreatitis, esophageal cancer, stomach cancer, colon cancer, hepatitis B, hepatitis C, steatohepatitis, hepatic carcinoma) |
| Date of disclosure of the study information | 2018/04/26 |
| Last modified on | 2021/04/28 13:05:48 |
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Basic information
Public title
Study of correlation between in vivo oxidative stress resistance parameters of the peripheral blood by biochemical test data and the multimodal homeostasis evaluation system in the gastrointestinal disease patients (Inflammatory bowel disease, pancreatitis, esophageal cancer, stomach cancer, colon cancer, hepatitis B, hepatitis C, steatohepatitis, hepatic carcinoma)
Acronym
Study of correlation between in vivo oxidative stress resistance parameters by biochemical test data and the multimodal homeostasis evaluation system in the gastrointestinal disease patients
Scientific Title
Study of correlation between in vivo oxidative stress resistance parameters of the peripheral blood by biochemical test data and the multimodal homeostasis evaluation system in the gastrointestinal disease patients (Inflammatory bowel disease, pancreatitis, esophageal cancer, stomach cancer, colon cancer, hepatitis B, hepatitis C, steatohepatitis, hepatic carcinoma)
Scientific Title:Acronym
Study of correlation between in vivo oxidative stress resistance parameters by biochemical test data and the multimodal homeostasis evaluation system in the gastrointestinal disease patients
Region
| Japan |
Condition
Condition
Inflammatory bowel disease, pancreatitis, esophageal cancer, stomach cancer, colon cancer, hepatitis B, hepatitis C, steatohepatitis, hepatic carcinoma
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the correlation between the blood test result and the evaluation value of the oxidative stress resistance parameter and the evaluation value of the inflammatory marker protein.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Assess the correlation between the blood test result and the evaluation value of the oxidative stress resistance parameter and the evaluation value of the inflammatory marker protein.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastrointestinal disease patients (Inflammatory bowel disease, pancreatitis, esophageal cancer, stomach cancer, colon cancer, hepatitis B, hepatitis C, steatohepatitis, hepatic carcinoma) who are visiting or hospitalized at Kagawa University hospital and scheduled to undergo blood test.
Key exclusion criteria
1) Person who has a history of malignant tumor other than gastrointestinal cancer within 5 years
2) Persons who are in diseases / conditions (hemolytic anemia, DIC, TTP, HUS, etc.) that exhibit intravascular hemolysis
3) Persons judged to be difficult to undertake this clinical trial by merging psychosis or psychiatric symptoms
4) During pregnancy or having a possibility of pregnancy
5) Persons judged inappropriate by the attending physician
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Masaki |
Organization
Faculty of Medicine, Kagawa University.
Division name
Department of Gastroenterology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, Japan
TEL
087-891-2156
tmasaki@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Masaki |
Organization
Faculty of Medicine, Kagawa University.
Division name
Department of Gastroenterology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, Japan
TEL
087-891-2156
Homepage URL
tmasaki@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Faculty of Medicine, Kagawa University.
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office, Government Of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
･Control of Innate Immunity Technology Research Association
･Hamamatsu Photonics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki, Kita
Tel
0878985111
chiken@med.kagawa-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
香川大学医学部（香川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Partially published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
20
Results
In 8 cases of esophageal cancer, MPO activity and O2 activity tended to be higher than the average of healthy subjects. In 12 cases of gastric cancer, MPO activity was significantly higher than the average of healthy subjects. In addition, O2 tended to be higher, although there was no significant difference. In 7 cases of early-stage esophageal cancer, phagocytic phagocytosis was inversely correlated with plasma TNFa and IL-6 levels (TNF R=-0.64, IL-6 R=-0.94).
Results date posted
| 2021 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We measured blood samples collected from 8 cases of esophageal cancer (7 early stage, 1 advanced stage) and 12 cases of gastric cancer (8 early stage, 4 advanced stage) using this developed system. The data of 820 healthy subjects were used as a control group.
Participant flow
Eight esophageal cancer cases (7 early stage, 1 advanced stage) and 12 gastric cancer cases (8 early stage, 4 advanced stage) that were last diagnosed between January and August 2018 under the approval of the ethics committee of our university and collaborating institutions were measured for blood samples using this developed system.
Adverse events
N/A
Outcome measures
Neutrophil activity is MPO activity and O2- production capacity after PMA stimulation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 28 | Day |
Other
Other related information
Assess the correlation between the blood test result and the evaluation value of the oxidative stress resistance parameter and the evaluation value of the inflammatory marker protein.
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036194
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