UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047709 |
|---|---|
| Receipt number | R000054399 |
| Scientific Title | Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study. |
| Date of disclosure of the study information | 2022/05/10 |
| Last modified on | 2022/05/10 20:37:08 |
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Basic information
Public title
Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study.
Acronym
Gastric cancer after Helicobacter pylori eradication study.
Scientific Title
Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study.
Scientific Title:Acronym
Gastric cancer after Helicobacter pylori eradication study.
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the endoscopic diagnostic performance of early gastric cancer detected after H. pylori eradication compared with that of gastric cancer presently infected with H. pylori.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the qualitative diagnostic performance of M-NBI observation using the vessel plus surface classification system for early gastric cancer detected after H. pylori eradication and early gastric cancer currently infected with H. pylori.
Key secondary outcomes
1. To compare the qualitative diagnostic performance of conventional white-light observation including dye endoscopic observation using color plus surface classification system for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori.
2. To compare the diagnostic performance of M-NBI and C-WLI+CE for the horizontal extent of early gastric cancer by M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori.
3. To compare the diagnostic performance of M-NBI and C-WLI+CE for the diagnosis of gastric carcinoma after H. pylori eradication and gastric carcinoma infected with H. pylori by histopathological classification into low atypia and other lesions.
4. To compare the range diagnostic performance of M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori according to the presence or absence and extent of noncancerous epithelial covering on the surface of intramucosal carcinoma nests.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with early-stage gastric cancer who are scheduled to undergo endoscopic or surgical resection with a diagnosis of Vienna Classification Category 4 or 5 on biopsy histopathology of the lesion.
2. Patients with ECOG-performance status 0 or 1.
3. Patients must be at least 20 years of age at the time of consent.
4. Patients who have given written consent to participate in the study.
Key exclusion criteria
1. Patients with postoperative stomach or gastrointestinal tract.
2. Patients who are determined to be Helicobacter pylori uninfected.
3. Patients who are judged by the physician to have a serious underlying disease such as cerebral infarction or severe heart failure.
4. Patients who are judged by the investigator or subinvestigator to be inappropriate to conduct this study.
5. Patients with gastric cancer detected by endoscopy less than 6 months after Helicobacter pylori eradication.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
8188502
Address
1-1-1 Zokumyoin Chikushino-city Fukuoka Japan
TEL
+81929211011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Hirase |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin Chikushino-city Fukuoka Japan
TEL
+81929211011
Homepage URL
d.r.g.b0116@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
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 committee of Fukuoka University
Address
7-45-1, Nanakuma, Jonan Ward, Fukuoka City, Fukuoka
Tel
+81928011011
fumed-ethics@fukuoka-u.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
福岡大学筑紫病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | 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
no related information
Management information
Registered date
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054399
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