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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044040
Receipt No. 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

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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
Email 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
Email imu_nori0111@yahoo.co.jp

Sponsor
Institute Takeda general hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050203

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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