UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044040 |
|---|---|
| Receipt number | R000050203 |
| Scientific Title | Clinical differences of c-Myc Expression in early stage gastric cancer: A retrospective study |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/26 12:05:49 |
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Basic information
Public title
Clinical differences of c-Myc Expression in early stage gastric cancer: A retrospective study
Acronym
Clinical differences of c-Myc Expression in early stage gastric cancer
Scientific Title
Clinical differences of c-Myc Expression in early stage gastric cancer: A retrospective study
Scientific Title:Acronym
Clinical differences of c-Myc Expression in early stage gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the differences in c-Myc expression in early gastric neoplasia based on the nuclear grade.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the study is an hierarchical cluster analysis based on the scores obtained by c-Myc staining to clarify the characteristics of each group.
Key secondary outcomes
The secondary endpoints of the study are a c-Myc expression rate in early gastric neoplasia based on the WHO classification, and the comparison of c-Myc expression intensity between mucosal and invasive areas in submucosal invasive carcinoma.
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
1) early gastric caner (differentiated type) patient.
2) Patient who agree to participate in this trial by written informed consent.
3) Subjects aged over 20 years old.
Key exclusion criteria
Excluding mixed tissue types (cases in which a component of the secondary tissue type accounted for more than 10% of the total, or cases in which the component of the secondary tissue type was small but included poorly differentiated cancer).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Arakawa |
Organization
Takeda general hospital
Division name
Department of Gastroenterology
Zip code
965-8585
Address
3-27 Yamagamachi, Aizu Wakamatsu-shi, Fukushima, 965-8585. JAPAN
TEL
0242-27-5511
imu_nori0111@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Arakawa |
Organization
Takeda general hospital
Division name
Department of Gastroenterology
Zip code
965-8585
Address
3-27 Yamagamachi, Aizu Wakamatsu-shi, Fukushima, 965-8585. JAPAN
TEL
0242-27-5511
Homepage URL
imu_nori0111@yahoo.co.jp
Sponsor or person
Institute
Takeda general hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Takeda general hospital
Address
3-27 Yamagamachi, Aizu Wakamatsu-shi, Fukushima, 965-8585. JAPAN
Tel
0242-27-5511
imu_nori0111@yahoo.co.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
| 2021 | Year | 05 | Month | 01 | 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
100
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
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
The pathological diagnosis is made by hematoxylin and eosin staining. Immunostaining is performed on representative sections following speculum examination.
Management information
Registered date
| 2021 | Year | 04 | Month | 26 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050203
| 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 |
