UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031302 |
|---|---|
| Receipt number | R000035504 |
| Scientific Title | Metachronous gastric cancer prevention with aspirin:A multi-center randomized trial |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2020/04/10 14:41:15 |
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Basic information
Public title
Metachronous gastric cancer prevention with aspirin:A multi-center randomized trial
Acronym
MEGA trial
Scientific Title
Metachronous gastric cancer prevention with aspirin:A multi-center randomized trial
Scientific Title:Acronym
MEGA trial
Region
| Japan | Asia(except Japan) |
Condition
Condition
Patients who underwent endoscopic submucosal dissection (ESD) for early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to test the hypothesis that aspirin can reduce the occurrence of metachronous gastric cancer after ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence rate of metachronous gastric carcinoma at 5 years after ESD.
Key secondary outcomes
Adverse events rate
Histological evaluation of gastric mucosal atrophy and intestinal metaplasia
Microbiota changes in stool and oral swab
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin 81 mg once daily for up to 5 years
Interventions/Control_2
Nothing
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Achieved absolute or expanded curative resection with ESD defined as per JGCA guidelines
2) Aged 20-80 years
3) Performance Status (ECOG) 0, 1, or 2
4) H. pylori infection was eradicated within 5 years or negative before enrollment
5) Will be followed over 5 years
6) Written informed consent
Key exclusion criteria
1) Allergy to aspirin treatment
2) Other gastric neoplasm including low grade adenoma remain
3) A history of H. pylori eradication therapy received more than 5 years ago
4) Lesions of Siewert Type II (<2 cm from the OGJ at the epicenter)
5) A history of gastric surgery
6) Severe co-morbidities and estimated life expectancy less than 3 years
7) Already on aspirin or other antithrombotic drugs prior to randomization
8) Using NSAIDs
9) Using Metformin
10) A history of peptic ulcers
11) A history of stroke
12) Receiving chemotherapy
13) Disorder of blood coagulation or platelet < 100,000/microliter
14) Pregnancy
15) Breast-feeding
16) Lack of informed consent
Target sample size
1120
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Gotoda |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
takujigotoda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
Homepage URL
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
MEGA trial Group
Institute
Department
Personal name
Funding Source
Organization
Japan Strategic Medical Administration Research Center: J-SMARC
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
Institutional Review Board of Nippon Medical School Foundation
Address
1-1-5, Sendagi, Bunkyoku, Tokyo, Japan
Tel
03-5802-8202
officetokutei@nms.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
| 2018 | Year | 02 | Month | 14 | 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
50
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
Terminated
Date of protocol fixation
| 2019 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 14 | Day |
Last modified on
| 2020 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035504
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