UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014496 |
|---|---|
| Receipt number | R000016859 |
| Scientific Title | Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2022/01/10 18:36:35 |
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Basic information
Public title
Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Acronym
Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Scientific Title
Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Scientific Title:Acronym
Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Region
| Japan |
Condition
Condition
H. pylori-infected gastritis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this pilot study is to evaluate the diagnostic utility of plasma ghrelin levels to predict the severity of gastric mucosal atrophy after H. pylori eradication better than serum pepsinogen levels.
Basic objectives2
Others
Basic objectives -Others
evaluation of a novel risk stratification marker
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of plasma ghrelin levels during the H. pylori eradication therapy
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
Patients who visit Keio University Hospital for H. pylori eradication therapy.
They are planning to undergo esophagogastroduodenoscopy.
Key exclusion criteria
Patients after a laparotomy for the resection of esophagus or stomach
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Suzuki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3914
hsuzuki@a6.keio.jp
Public contact
Name of contact person
| 1st name | Juntaro |
| Middle name | |
| Last name | Matsuzaki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3914
Homepage URL
juntaro.matsuzaki@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Tosoh Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2014 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000016859
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000016859
Number of participants that the trial has enrolled
27
Results
Total and acyl plasma ghrelin levels demonstrated no significant change from before treatment to 48 weeks after eradication; however, there was a significant difference between open-type and closed-type atrophic gastritis. The PG I/II ratio increased significantly from 48 weeks after H. pylori eradication. The severity of the histological intestinal metaplasia scores correlated inversely with plasma total ghrelin levels from before to 48 weeks after H. pylori eradication.
Results date posted
| 2022 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The severity of atrophic gastritis is significantly associated with the risk of gastric cancer. Although the current gold standard for assessing the gastric cancer risk is esophagogastroduodenoscopy with a pathological examination, the development of less-invasive biomarkers is warranted for efficient risk stratification of gastric cancer. Serum pepsinogens (PGs) are biomarkers used to predict the extent of gastric mucosal atrophy; however, they are not an accurate reflection of gastric mucosal atrophy after Helicobacter pylori eradication. The present study was conducted to investigate the usefulness of plasma ghrelin levels as a marker for gastric mucosal atrophy, and as a risk stratification marker for gastric cancer, even after H. pylori eradication.
Participant flow
Patients who received H. pylori eradication treatment were enrolled in the study. The severity of gastric mucosal atrophy was evaluated both endoscopically and histologically. Serum pepsinogen and plasma ghrelin levels were measured before and at 1, 12, 24, and 48 weeks after treatment. The study was approved by the Research Ethics Committee of the Keio University School of Medicine (no. 20140102; July 8, 2014).
Adverse events
None
Outcome measures
The severity of gastric mucosal atrophy was evaluated both endoscopically and histologically. Serum pepsinogen and plasma ghrelin levels were measured before and at 1, 12, 24, and 48 weeks after treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | 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
In this study, we will observe the following items before and after H. pylori eradication therapy.
1. Blood exam including plasma ghrelin levels, serum pepsinogen levels (before eradication/ 1 week, 3 months, 6 months, 1 year after eradication)
2. Esophagogastroduodenoscopy (before eradication, 1 year after eradication)
Management information
Registered date
| 2014 | Year | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016859
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| Registered date | File name |
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