UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016643 |
|---|---|
| Receipt number | R000019319 |
| Scientific Title | The study of investigating the genetic profiles of Exceptional Response in cancer therapies. |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2024/03/04 09:57:29 |
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Basic information
Public title
The study of investigating the genetic profiles of Exceptional Response in cancer therapies.
Acronym
The study of investigating the genetic profiles of Exceptional Response in cancer therapies.
Scientific Title
The study of investigating the genetic profiles of Exceptional Response in cancer therapies.
Scientific Title:Acronym
The study of investigating the genetic profiles of Exceptional Response in cancer therapies.
Region
| Japan |
Condition
Condition
Cancer patient who received therapies.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the genome profiles of Exceptional Response in cancer therapies.
Basic objectives2
Others
Basic objectives -Others
Gene profiling
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of somatic gene mutation, gene expression of tumor tissue
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
1)Cancer patient who will receive therapies
2)Samples meeting one of the followings:
1.Surplus sample stored in the NCC biobank
2.Surplus sample diagnostic biopsy
3.Surgical surplus tumor sample
Key exclusion criteria
Judged ineligible by the clinical investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
takoyama@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
takoyama@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Project for Development of Innovative Research on Cancer Therapeutics
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、北海道大学病院（北海道）、東京慈恵会医科大学附属病院（東京都）、日本医科大学付属病院（東京都）、神奈川県立こども医療センター（神奈川県）、群馬大学医学部附属病院（群馬県）、関西医科大学附属枚方病院（大阪府）、大阪医科大学附属病院（大阪府）、久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 26 | 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
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019319
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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