UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014209 |
|---|---|
| Receipt number | R000016550 |
| Scientific Title | Biomarker study using cell free DNA in patients with gastric cancer |
| Date of disclosure of the study information | 2014/06/09 |
| Last modified on | 2014/06/09 16:47:38 |
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Basic information
Public title
Biomarker study using cell free DNA in patients with gastric cancer
Acronym
Cell-free DNA in CG
Scientific Title
Biomarker study using cell free DNA in patients with gastric cancer
Scientific Title:Acronym
Cell-free DNA in CG
Region
| Japan |
Condition
Condition
advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate somatic mutations and expression levels of cytokines as a predictive biomarker for anti-cancer therapy in plasma and tumor tissues from patients with advanced gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the association between the presence of some somatic mutations and expression levels of cytokines in plasma and efficacy of some anti-tumor drugs.
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
those who gave an informed consent about this study.
Key exclusion criteria
none
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakagawa |
Organization
Kindai University Faculty of Medicine
Division name
Medical Oncology Department
Zip code
Address
377-2 Ohnohigashi, Osakasayama
TEL
072-366-0221
nakagawa@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Tsurutani |
Organization
Kindai University Faculty of Medicine
Division name
Medical Oncology Department
Zip code
Address
377-2 Ohnohigashi, Osakasayama
TEL
072-366-0221
Homepage URL
tsurutani_j@dotd.med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 06 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Statistical consideration is applied to this study.
Management information
Registered date
| 2014 | Year | 06 | Month | 09 | Day |
Last modified on
| 2014 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016550
| 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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| Registered date | File name |
