UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030793 |
|---|---|
| Receipt number | R000035165 |
| Scientific Title | Exploration of predictive and prognostic factor in gastrointestinal cancer |
| Date of disclosure of the study information | 2018/01/13 |
| Last modified on | 2019/07/23 15:41:44 |
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Basic information
Public title
Exploration of predictive and prognostic factor in gastrointestinal cancer
Acronym
Exploration of predictive and prognostic factor in gastrointestinal cancer
Scientific Title
Exploration of predictive and prognostic factor in gastrointestinal cancer
Scientific Title:Acronym
Exploration of predictive and prognostic factor in gastrointestinal cancer
Region
| Japan |
Condition
Condition
Gastric cancer, Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate genetic status for investigating biomarker of gastrointestinal cancer
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of genetic status
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with Colorectal cancer or Gastric cancer histologically, who treated at Kanagawa Cancer Center.
Key exclusion criteria
None
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
shiozawam@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama City University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
045-520-2222
chiken-jim4@kcch.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 | 01 | Month | 13 | 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
| 2017 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the relationship between the presence or absence of protein expression and response rate and survival rate
Management information
Registered date
| 2018 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035165
