UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023392 |
|---|---|
| Receipt number | R000026952 |
| Scientific Title | A comprehensive gene profile investigation of the patients with high risk etiology of colorectal cancer |
| Date of disclosure of the study information | 2016/07/29 |
| Last modified on | 2020/03/01 09:25:55 |
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Basic information
Public title
A comprehensive gene profile investigation of the patients with high risk etiology of colorectal cancer
Acronym
A comprehensive gene profile investigation of the patients with colorectal cancer
Scientific Title
A comprehensive gene profile investigation of the patients with high risk etiology of colorectal cancer
Scientific Title:Acronym
A comprehensive gene profile investigation of the patients with colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
to clarify the gene mutation profile of colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
to crarify the comprihensive profile of cororectal cancer with NGS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Somatic and germline mutation of cororeactal cancer.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
We perform fenetic analysis of tumor, non-tumor, plasma, buffy coat of patients of colorectal cancer.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with colorectal cancer.
patinents with previous treatment of colorectal cancer.
patients with multiple colorectal cancer.
Key exclusion criteria
patients with FAP
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba university
Division name
gastroenterology and neohrology
Zip code
Address
1-8-1 Cyuo ward Chiba city
TEL
043-222-7171
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba university
Division name
gastroenterology and neohrology
Zip code
Address
043-222-7171
TEL
043-222-7171
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
self financing
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 29 | 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
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study is ongoing
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026952
