UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051417 |
|---|---|
| Receipt number | R000058652 |
| Scientific Title | A multicenter prospective cohort study regarding the relationship between CYP2E1 or CYP2A6 polymorphism and multiple gastric cancers |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2023/06/22 18:04:24 |
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Basic information
Public title
A multicenter prospective cohort study regarding the relationship between CYP2E1 or CYP2A6 polymorphism and multiple gastric cancers
Acronym
Tohoku GI-P study
Scientific Title
A multicenter prospective cohort study regarding the relationship between CYP2E1 or CYP2A6 polymorphism and multiple gastric cancers
Scientific Title:Acronym
Tohoku GI-P study
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To reveal the relationship between CYP2E1 or CYP2A6 polymorphism and multiple gastric cancers in patients after endoscopic submucosal dissection (ESD) for the initial early gastric cancers (EGCs)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between CYP2A6 polymorphism and multiple gastric cancers
Key secondary outcomes
1. The relationship among CYP2A6 polymorphism, the amount of smoking, duration of smoking, and metachronous gastric cancers
2. The relationship among CYP2A6 polymorphism, the amount of smoking, duration of smoking, and metachronous gastric cancers
3. The relationship among CYP2A6 polymorphism, the amount of smoking, duration of smoking, and metachronous gastric cancers
4. The relationship between the duration of cessation and metachronous gastric cancers in each CYP2A6 polymorphism
5. The relationship between CYP2E1 polymorphism and multiple gastric cancers
6. The relationship among CYP2E1 polymorphism, the amount of drinking, duration of drinking, and multiple gastric cancers
7. The relationship among CYP2E1 polymorphism, the amount of drinking, duration of drinking, and synchronous gastric cancers
8. The relationship among CYP2E1 polymorphism, the amount of drinking, duration of drinking, and metachronous gastric cancers
9. The relationship between the duration of abstinence and metachronous gastric cancers in each CYP2E1 polymorphism
10. The relationship among ADH1B, ALDH2, and CYP2E1 polymorphisms, drinking, and multiple gastric cancers
11. The relationship among CYP2A6 and CYP2E1 polymorphisms, smoking, drinking, and esophageal cancers
12. The relationship between CEA and multiple gastric cancers
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
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled in the Tohoku GI study (UMIN000023385) (registration: 2016-2019) and those in whom informed consent for participating in this study are acquired will be enrolled in this study. The inclusion and exclusion criteria for that study are as follows.
<Inclusion criteria in a study of UMIN000023385>
1. Patients with first early gastric cancers which will be treated by ESD
2. Patients with 0-2 of performance status (PS) in an Eastern Cooperative Oncology Group (ECOG) criteria
3. Patients agreeing with the participation of this study
<Inclusion criteria in a study of UMIN000023385>
1. Patients with a history of endoscopic resection for early gastric cancers
2. Patients with a history or a plan of gastrectomy
3. Patients with a history or a plan of chemotherapy for gastric cancers
4. Patients with a history or a plan of surgery, chemotherapy, or radiation therapy for esophageal cancers
5. Patients with a history of chemotherapy for malignant tumors excluding gastric or esophageal cancers within 5 years
6. Patients with malignant tumors except for gastric or esophageal cancers who have a plan for endocrine therapy, chemotherapy, or radiation at the time of enrollment
7. Patients with early gastric cancers which did not meet the curative resection for ESD in the guidelines
8. Patients with gastric lesions diagnosed as Group 4 in the preoperative diagnosis resulting as no cancer in the pathological diagnosis of ESD specimen
9. Patients with pregnancy or breast-feeding
10. Patients with severe psychiatric disease
11. Patients regard as inappropriate for enrollment by the researcher
12. Patients whose serum creatinine level are 2.0 mg/dL or more
13. Patients who cannot understand Japanese language
Key exclusion criteria
None
Target sample size
680
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Waku |
| Middle name | |
| Last name | Hatta |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177171
Homepage URL
waku-style@festa.ocn.ne.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Tomoyuki Koike
Funding Source
Organization
Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 06 | Month | 22 | 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 | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | 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
Tohoku GI study (UMIN000023385) is now ongoing, and its sample size was set as 850. In this study, cases with follow out and refuse to this study were expected to be 10% each. Thus, the sample size in this study was set as 680.
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058652
| 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 |
