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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000047709 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Early gastric cancer | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Fukuoka University Chikushi Hospital |
Institute | |
Department |
Funding Source | |
Organization | Fukuoka University Chikushi Hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | no related information |
Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054399 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |