UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033554 |
|---|---|
| Receipt number | R000038262 |
| Scientific Title | The study for predictive markers of vessel invasion of gastric cancer |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2022/02/04 11:42:17 |
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Basic information
Public title
The study for predictive markers of vessel invasion of gastric cancer
Acronym
The study for predictive markers of vessel invasion of gastric cancer
Scientific Title
The study for predictive markers of vessel invasion of gastric cancer
Scientific Title:Acronym
The study for predictive markers of vessel invasion of gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze whether the results of immunohistochemical staining of biopsy specimens correlate to the degree of vessel invasion of resection specimens
Basic objectives2
Others
Basic objectives -Others
To analyze whether the results of immunohistochemical staining of biopsy specimens correlate to the degree of vessel invasion of resection specimens, and to investigate the predictive markers of vessel invasion of gastric cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Discrimination ability of vessel invasion by immunohistochemical staining of beta-catenin, E-cadherin, sox10 and EGFR
1. The relevance between the membrane positive rate of beta-catenin and the degree of vessel invasion
2. The relevance between the membrane positive rate of E-cadherin and the degree of vessel invasion
3. The relevance between the positive rate of sox10 and the degree of vessel invasion
4. The relevance between the positive rate of EGFR and the degree of vessel invasion
Key secondary outcomes
1. The concordance rate of histology of biopsy specimen and resection specimen
2. The concordance rate of immunohistochemistry of biopsy specimen and resection specimen
3. The relevance between vessel invasion and histology
4. The relevance between vessel invasion and infiltration type
5. The relevance between vessel invasion and progression free survival
6. The relevance between vessel invasion and overall survival
7. The relevance between the result of immunohistochemical staining of each molecule and histology
8. The relevance between the result of immunohistochemical staining of each molecule and infiltration type
9. The relevance between the result of immunohistochemical staining of each molecule and progression free survival
10. The relevance between the result of immunohistochemical staining of each molecule and overall survival
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 who are 20 years of age or older at the time of obtaining informed consent
2. Patients who are diagnosed as gastric cancer by biopsy
3. Patients who are resected stomach as treatment for gastric cancer
4. Patients who are informed and have provided written informed consent to participate in the study prior to study initiation
Key exclusion criteria
1. Patients by whom principal investigator has determined to be inappropriate as a subject
Target sample size
153
Research contact person
Name of lead principal investigator
| 1st name | Shouko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0608648
Address
North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL
+81-11-716-1161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Marin |
| Middle name | |
| Last name | Ishikawa |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
0608648
Address
North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL
+81-11-716-1161
Homepage URL
marin.0719@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Audit Committee, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido, Japan
Tel
+81-11-706-7636
crjimu@huhp.hokudai.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
| 2018 | Year | 08 | 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
128
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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. The relevance between the membrane positive rate of beta-catenin and the degree of vessel invasion
2. The relevance between the membrane positive rate of E-cadherin and the degree of vessel invasion
3. The relevance between the positive rate of sox10 and the degree of vessel invasion
4. The relevance between the positive rate of EGFR and the degree of vessel invasion
Management information
Registered date
| 2018 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038262
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