UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027023 |
|---|---|
| Receipt number | R000030975 |
| Scientific Title | A multicenter prospective study of the endoscopic findings of gastric mucosa in background of gastric cancer |
| Date of disclosure of the study information | 2017/04/20 |
| Last modified on | 2019/04/19 16:01:19 |
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Basic information
Public title
A multicenter prospective study of the endoscopic findings of gastric mucosa in background of gastric cancer
Acronym
Gastric Mucosa in Background of Gastic Cancer
Scientific Title
A multicenter prospective study of the endoscopic findings of gastric mucosa in background of gastric cancer
Scientific Title:Acronym
Gastric Mucosa in Background of Gastic Cancer
Region
| Japan |
Condition
Condition
gastric cancer/gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify higher risk of endoscopic findings in background mucosa of gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the differentiation of each endoscopic findings in background mucosa according to Kyoto classification between patients with gastric cancer and non-gastric cancer
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Perfomance status 0-2.
Patients who will undergo endoscopic examination at relative institutions.
Patients who agree with investigation for H .pylori infection and gastritis.
Key exclusion criteria
Cases with hematemesis or hematochezia
Cases who are less than 20 years old
Cases with surgical gastrectomy
Cases with endoscopic mucosal resection for gastric cancer
Cases that investigator has determined to be inappropriate.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kawamura |
Organization
Sendai City Hospital, Miyagi, Japan
Division name
Department of Gastroenterology
Zip code
9828502
Address
1-1-1, Asutonagamachi, Taihaku-ku, Sendai, Miyagi 982-8502, Japan.
TEL
+81223087111
dq8m-kwmr@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kawamura |
Organization
Sendai City Hospital, Miyagi, Japan
Division name
Department of Gastroenterology
Zip code
9828502
Address
1-1-1, Asutonagamachi, Taihaku-ku, Sendai, Miyagi 982-8502, Japan.
TEL
+81223087111
Homepage URL
dq8m-kwmr@asahi-net.or.jp
Sponsor or person
Institute
Sendai City Hospital, Miyagi, Japan
Institute
Department
Personal name
Funding Source
Organization
Sendai City Hospital, Miyagi, Japan
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
Sendai City Hospital, Miyagi, Japan
Address
1-1-1, Asutonagamachi, taihaku-ku, Sendai, Miyagi, Japan
Tel
+81223087111
dq8m-kwmr@asahi-net.or.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
| 2017 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopic findings: atrophy, grayish white change, diffuse redress, nodular change, RAC, Map-like redress, WOS, LBC
Management information
Registered date
| 2017 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030975
