UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023385 |
|---|---|
| Receipt number | R000025088 |
| Scientific Title | A prospective cohort study of factors associated with synchronous and metachronous gastric and esophageal cancers after endoscopic submucosal dissection for early gastric cancers |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2021/03/10 21:48:02 |
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Basic information
Public title
A prospective cohort study of factors associated with synchronous and metachronous gastric and esophageal cancers after endoscopic submucosal dissection for early gastric cancers
Acronym
Tohoku GI study
Scientific Title
A prospective cohort study of factors associated with synchronous and metachronous gastric and esophageal cancers after endoscopic submucosal dissection for early gastric cancers
Scientific Title:Acronym
Tohoku GI study
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the factors associated with metachronous and synchronous gastric and esophageal cancers in patients after endoscopic submucosal dissection (ESD) for primary early gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 5-year cumulative incidence rate of metachronous gastric cancers according to smoking in Helicobacter pylori (H. pylori)-eradicated patients who underwent ESD for early gastric cancers
Key secondary outcomes
1) The association between the incidence of metachronous gastric cancer (MGC) and smoking, drinking, body mass index, diabetes mellitus, preferences for salty taste, intake of green vegetables, intake of green tea, gastric atrophy diagnosed by endoscopy, and pepsinogen (PG) level before eradication of H. pylori
2) The association between the incidence of MGC and the detailed information of smoking
3) The establishment of cut-off value of PG level after H. pylori eradication for predicting the incidence of MGC
4) The comparison of cumulative incidence rate of MGC between H. pylori-eradicated cases and H. pylori-negative cases (those who never underwent H. pylori eradication)
5) The association between incidence of MGC and PG level before eradication of H. pylori
6) The association between incidence of MGC and change rate of PG level before and after eradication of H. pylori
7) The association between incidence of synchronous gastric cancer and factors related to life-style, H. pylori, and PG level
8) The incidence rate of esophageal cancer and factors associated with the incidence of esophageal cancer in patients who underwent ESD for early gastric cancer
9) The cumulative incidence rate of MGC and factors associated with the incidence of MGC in patients who underwent ESD for primary early gastric cancer that occurred in H. pylori-eradicated patients
10) The location of MGC
11) The association between incidence of synchronous gastric cancer and ALDH2-genotype, ADH1B-genotype, or the alcohol intake
12) The association between incidence of MGC and ALDH2-genotype, ADH1B-genotype, the alcohol intake, or cessation of drinking
13) The association between incidence of esophageal cancer in patients who underwent ESD for early gastric cancer and ALDH2-genotype, ADH1B-genotype, the alcohol intake, or cessation of drinking
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
(1) Patients with primary early gastric cancers that are scheduled to undergo ESD
(2) Patients with 0-2 in performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) criteria
(3) Patients who agreed and turned in the written agreement for participation of this study
Key exclusion criteria
(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
Target sample size
850
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
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7171
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
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7171
Homepage URL
waku-style@festa.ocn.ne.jp
Sponsor or person
Institute
Division of gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Comittee, Tohoku University Graduate School of Medicine
Address
1-1 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
| 2016 | Year | 08 | Month | 01 | 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
850
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In H. pylori-infected patients, H. pylori eradication will be performed, and their serum PG will be measured. Examination by esophagogastroduodenoscopy (EGD) will be performed 6 months after ESD for early gastric cancer. Annual EGD and assessment of smoking and drinking will be performed after ESD.
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025088
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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