UMIN-CTR Clinical Trial

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
Email	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
Email	waku-style@festa.ocn.ne.jp

Sponsor
Institute	Division of gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025088