UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053046 |
|---|---|
| Receipt number | R000060522 |
| Scientific Title | Study of cytokine kinetics in patient plasma under cardiopulmonary bypass and their effects on pancreatic cancer cells. |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2023/12/09 22:37:00 |
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Basic information
Public title
How does the patient's blood exposed by cardiopulmonary bypass affect pancreatic cancer cells in mice.
Acronym
Effect of cardiopulmonary bypass on Pancreatic Cancer Cells
Scientific Title
Study of cytokine kinetics in patient plasma under cardiopulmonary bypass and their effects on pancreatic cancer cells.
Scientific Title:Acronym
Effect of cardiopulmonary bypass on Pancreatic Cancer Cells
Region
| Japan |
Condition
Condition
Cardiovascular disease requiring surgery with cardiopulmonary bypass.
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to investigate the dynamics of plasma cytokines in patients undergoing cardiac surgery using cardiopulmonary ventilation before and after the use of cardiopulmonary ventilation, and to examine their effects on cancer cells (proliferative capacity, invasive capacity, metastatic capacity) in vitro.
Basic objectives2
Others
Basic objectives -Others
To investigate changes in blood cytokine levels and cytokine-mediated effects on cancer cells before and after the use of cardiopulmonary bypass during general anesthesia.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in plasma cytokines before and after use of cardiopulmonary bypass.
Key secondary outcomes
Investigation of proliferative, invasive and metastatic potential of pancreatic cancer cells using blood samples before and after the use of cardiopulmonary bypass.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who are between 20 and 65 years of age at the time of consent
2) Patients who have given a sufficient explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
3) Patients with an American Society of Anesthesiologists pre-anesthesia risk assessment of 4 or less (ASA classification 1: no organic, physiological, biochemical, or psychiatric abnormalities; 2: mild to moderate systematic disorder; 3: severe systematic disorder; 4: severe systematic disorder that is life-threatening and may not be curable even if surgery is performed; 5: severe systematic disorder that is life-threatening; 6: severe systematic disorder that is not curable even if surgery is performed; 7: severe systematic disorder that is not curable even if surgery is performed; 8: severe systematic disorder that is not curable even if surgery is performed. 5: A dying condition.)
Key exclusion criteria
1) Patients with cancer or a history of surgery for malignant tumors
2) Patients with poorly controlled diabetes mellitus (HbA1c > 8.0%)
3) Patients with severe renal dysfunction (eGFR < 30%)
4)Patients with severe hepatic dysfunction (Child-Pugh C)
5) Patients taking steroids
6)Patients with inflammatory disease or infectious symptoms (surgical procedure for infective endocarditis)
7)Cases in which CPB is driven again, cases of circulatory arrest, and cases in which aortic blockade is not performed
8) Emergency surgery cases
9) Other patients deemed inappropriate as research subjects by the principal investigator
10) Patients who refuse to participate in this study.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Seidai |
| Middle name | |
| Last name | Katagiri |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
katagiri.seidai@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Seidai |
| Middle name | |
| Last name | Katagiri |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
katagiri.seidai@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon 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
Nihon University School of Medicine Itabashi Hospital Clinical Research Ethics Review Committee
Address
30-1, Oyaguchi Kamimachi, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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
| 2023 | Year | 12 | Month | 11 | 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
| 2023 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
open-label controlled study
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060522
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| Registered date | File name |
| Research case data | |
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