UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047435 |
|---|---|
| Receipt number | R000054087 |
| Scientific Title | Identification of the alternative splicing associated with gastric cancer |
| Date of disclosure of the study information | 2022/04/07 |
| Last modified on | 2022/04/07 21:08:15 |
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Basic information
Public title
Identification of the alternative splicing associated with gastric cancer
Acronym
Identification of the alternative splicing associated with gastric cancer
Scientific Title
Identification of the alternative splicing associated with gastric cancer
Scientific Title:Acronym
Identification of the alternative splicing associated with gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to comprehensively search for abnormal RNA molecules showing gastric cancer-specific expression by performing transcriptome analysis by RNA sequencing from gastric cancer tissue and to investigate whether the detected molecule can be detected by cell free RNA in blood as a biomarker.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of the alternative splicing associated with gastric cancer
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
(1) Patients aged 20 years or older
(2) Patients histologically diagnosed with adenocarcinoma in the primary gastric lesion
(3) Patients whose primary gastric lesion is deeper than cT2 and who are considered to be able to collect 3 tissue pieces for this study of 5x5x5 mm as tumor tissue specimens.
(4) Patients who are scheduled to have gastric cancer tumor removed (including non-curative resection) by surgery
(5) Patients who understood the written explanation of this study and signed the consent form by themselves.
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama medical university
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera,Wakayama 641-8510, JAPAN
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama 641-8510,JAPAN
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University, School of medicine
Institute
Department
Personal name
Funding Source
Organization
ZENICK LAB
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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama 641-8510,JAPAN
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2022 | Year | 04 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Identification of the alternative splicing associated with gastric cancer
Management information
Registered date
| 2022 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054087
| Research Plan | |
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| 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 |
