UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032077 |
|---|---|
| Receipt number | R000036592 |
| Scientific Title | Pilot study of comparing detection capability of genomic alterations by panel size in cancer genome analysis |
| Date of disclosure of the study information | 2018/04/03 |
| Last modified on | 2018/04/03 12:05:35 |
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Basic information
Public title
Pilot study of comparing detection capability of genomic alterations by panel size in cancer genome analysis
Acronym
Panel size comparison study
Scientific Title
Pilot study of comparing detection capability of genomic alterations by panel size in cancer genome analysis
Scientific Title:Acronym
Panel size comparison study
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to compare detection capability of two panels: small size and medium size panels.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of genomic alteration
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Having cancer diagnosis
-Age more than or equal to 20
-Can consent to the study
-Having diagnosis of following disease
-Cancer that becomes resistant or refractory to standard therapy
-Unknown primary
-Rare tumor
Key exclusion criteria
-Age less than 20
-Cannot consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadakatsu Ikeda |
Organization
Tokyo Medical and Dental University
Division name
Cancer center
Zip code
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
03-5803-4873
ikeda.canc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Iwata |
Organization
Tokyo Medical and Dental University
Division name
Cancer center
Zip code
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
03-5803-4873
Homepage URL
genome.canc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
ACT Genomics
Organization
Division
Category of Funding Organization
Outside Japan
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 | 04 | Month | 03 | 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
Suspended
Date of protocol fixation
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
NA
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036592
