UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034110 |
|---|---|
| Receipt number | R000038881 |
| Scientific Title | Analysis of impacts on clinical results by free cancer cells in gastric juices of the gastric cancer patients |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/09/12 17:44:32 |
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Basic information
Public title
Analysis of impacts on clinical results by free cancer cells in gastric juices of the gastric cancer patients
Acronym
Analysis of impacts on clinical results by free cancer cells in gastric juices of the gastric cancer patients
Scientific Title
Analysis of impacts on clinical results by free cancer cells in gastric juices of the gastric cancer patients
Scientific Title:Acronym
Analysis of impacts on clinical results by free cancer cells in gastric juices of the gastric cancer patients
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study on the presence and prognostic effects of free cancer cells in gastric juice of gastric cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of presence of free cancer cells in gastric juice
Key secondary outcomes
Reccurence Rate
Disease-Free Surviva
Progression-Free Survival
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) Histologically proven gastric
adenocarcinoma
2)Written informed consent from patient
Key exclusion criteria
1)With active double or multiple cancers
2)With active infection
3)Patients judged inappropriate for the study by the physicians
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dai Manka |
Organization
Kyoto Katsura Hospital
Division name
Department of Surgery, Gastro-Intestinal Center
Zip code
Address
Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL
075-391-5811
d_manaka@katsura.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayuri Konishi |
Organization
Kyoto Katsura Hospital
Division name
Department of Surgery, Gastro-Intestinal Center
Zip code
Address
Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL
075-391-5811
Homepage URL
sayurik0713@gmail.com
Sponsor or person
Institute
Kyoto Katsura Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2018 | Year | 10 | 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
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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
Not applicable
Management information
Registered date
| 2018 | Year | 09 | Month | 12 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038881
