UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033733 |
|---|---|
| Receipt number | R000038472 |
| Scientific Title | Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer |
| Date of disclosure of the study information | 2018/08/13 |
| Last modified on | 2018/08/13 15:34:12 |
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Basic information
Public title
Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Acronym
Prospective study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Scientific Title
Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Scientific Title:Acronym
Prospective study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main objective is to examine the accuracy and efficacy of AICS for early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positivity rate of AICS in early gastric cancer cases
Key secondary outcomes
Reduction rate of AICS value at 2 months and 1 year after resection of early gastric cancer in AICS positive cases
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 20 to 90 years old male and female who can examine AICS and endoscopic examination.
(2) Patients with early gastric cancer or suspicious of early gastric cancer that endoscopically resectable.
(3) Patients who have consent for examination and treatment on their own will.
Key exclusion criteria
(1)Patients with Barrett adenocarcinoma, advanced gastric cancer and obvious other organ cancer.
(2)Patients who are pregnant, may be pregnant, or prefer pregnancy during this study.
(3)Patients judged unsuitable as subjects by doctor.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kaneko |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama 236-0004, Japan
TEL
045-787-2326
hero5722@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kaneko |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama 236-0004, Japan
TEL
045-787-2326
Homepage URL
hero5722@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Center for Novel and Exploratory Clinical Trials
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 08 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional study of patients with early gastric cancer who meet all inclusion criterias and visit our institution after October 2018. Before performing endoscopic treatment, we measure AICS value. For AICS positive cases, we use it as a main analysis target and analyze the effectiveness of AICS for early gastric cancer.
Management information
Registered date
| 2018 | Year | 08 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038472
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
