UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012940 |
|---|---|
| Receipt number | R000015138 |
| Scientific Title | Gene mutation analysis such as FGF signaling in gastrointesitinal cancer |
| Date of disclosure of the study information | 2014/01/24 |
| Last modified on | 2022/08/01 10:11:59 |
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Basic information
Public title
Gene mutation analysis such as FGF signaling in gastrointesitinal cancer
Acronym
Gene mutation analysis such as FGF signaling in gastrointesitinal cancer
Scientific Title
Gene mutation analysis such as FGF signaling in gastrointesitinal cancer
Scientific Title:Acronym
Gene mutation analysis such as FGF signaling in gastrointesitinal cancer
Region
| Japan |
Condition
Condition
Cancer of digestive organs
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyse gene mutation such as Fibroblast Growth Factor (FGF) signaling in cancer of digestive organs.
Basic objectives2
Others
Basic objectives -Others
Analysisi of gene mutation and location in cancer of digestive organs.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and location of gene mutation such as FGF-FGFR signaling in cancer of digestive organs.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cancer in digestive organs (esophageal, gastric , biliary, pancreatic) whose paraffin-embedded samples by biopsy, endoscopic resection or surgery were obtained at St Marianna University School of Medicine Hospital .
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAKO NAKAJIMA |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
tnakajima@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKAKO NAKAJIMA |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
tnakajima@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinki University School of Medicine, Department of Genome Biology
Name of secondary funder(s)
Kinki University School of Medicine, Department of Genome Biology
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
| 2014 | Year | 01 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gene mutation analysis:
1. Gene mutation of FGF-FGFR pathway
2. Any new candidates of biomarker
Management information
Registered date
| 2014 | Year | 01 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015138
