UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030472 |
|---|---|
| Receipt number | R000034796 |
| Scientific Title | Validation of predictive and prognostic markers in upper gastrointestinal cancer |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2022/10/19 09:44:25 |
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Basic information
Public title
Validation of predictive and prognostic markers in upper gastrointestinal cancer
Acronym
Validation of predictive and prognostic markers
Scientific Title
Validation of predictive and prognostic markers in upper gastrointestinal cancer
Scientific Title:Acronym
Validation of predictive and prognostic markers
Region
| Japan |
Condition
Condition
Upper gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examine the utility of biomarkers as a predictor of survival in Upper gastrointestinal cancer
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cancer-specific survival
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histopathologically proven gastric cancer
2.20 years of age and older
90 yearrs of age and younger
3.ECOG performance status 0 or 1
4.No previous treatment (chemotherapy, radootherapy) for any cancer in recent 5 years
5.Patients who can take medecine orally
Key exclusion criteria
1.Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma, and multicentric cancer.
2.Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, heart failure, renal failure, liver cirrhosis, liver failure, etc.).
3.Patients with infections.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hirahara |
Organization
Shimane University Faculty of Medicine
Division name
Department of Digestive and General Surgery
Zip code
Address
89-1 Enya-cho, Izumo Shimane 693-8501
TEL
+81-853-20-2232
norinori@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hirahara |
Organization
Shimane University Faculty of Medicine
Division name
Department of Digestive and General Surgery
Zip code
Address
89-1 Enya-cho, Izumo Shimane 693-8501
TEL
+81-853-20-2232
Homepage URL
norinori@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 12 | Month | 20 | 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
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
No
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2022 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034796
| 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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