UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029779 |
|---|---|
| Receipt number | R000033819 |
| Scientific Title | Observational study for selection of targeted therapy based on (comprehensive) gene profiling of solid cancer |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2023/05/06 14:12:51 |
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Basic information
Public title
Observational study for selection of targeted therapy based on (comprehensive) gene profiling of solid cancer
Acronym
Observational study for selection of targeted therapy based on (comprehensive) gene profiling of solid cancer
Scientific Title
Observational study for selection of targeted therapy based on (comprehensive) gene profiling of solid cancer
Scientific Title:Acronym
Observational study for selection of targeted therapy based on (comprehensive) gene profiling of solid cancer
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
By using the platform of the next generation sequencing, etc., somatic mutation, copy number alteration, fusion gene etc. in tissue specimens of advanced solid cancer patients are measured. It aims to examine the clinical significance of clinical sequences that select treatment based on tumor genomic alteration.
Basic objectives2
Others
Basic objectives -Others
By using the platform of the next generation sequencing, etc., somatic mutation, copy number alteration, fusion gene etc. in tissue specimens of advanced solid cancer patients are measured. It aims to construct a gene mutation database of oncogene profiles.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
By using the platform of the next generation sequencing, etc., somatic mutation, copy number alteration, fusion gene etc. in tissue specimens of advanced solid cancer patients are measured. It aims to construct a gene mutation database of oncogene profiles and to examine the clinical significance of clinical sequences that select treatment based on tumor 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with pathologically diagnosed solid tumor (regardless of cytology or tissue biopsy)
2. Written informed consent from patient
Key exclusion criteria
Not applicable
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Nishio |
Organization
Kindai University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
589-8511
Address
377-2 Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Takahama |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
takahama_t@med.kindai.ac.jp
Sponsor or person
Institute
Department of Genome Biology, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Training Plan for Oncology Professionals from Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Ignyta, Inc.
IRB Contact (For public release)
Organization
Institutional Review Board of of Kindai University Faculty of Medicine
Address
377-2 Ohno-Higashi Osaka-Sayama, Osaka
Tel
072-366-0221
zizen@med.kindai.ac.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
近畿大学医学部腫瘍内科学教室（大阪府）
和歌山県立医科大学内科学第三講座（和歌山県）
北里大学医学部（神奈川県）
市立岸和田市民病院腫瘍内科（大阪府）
国立病院機構大阪南医療センター呼吸器腫瘍内科（大阪府）
近畿大学医学部奈良病院腫瘍内科（奈良県）
和泉市立病院腫瘍内科（大阪府）
神戸大学医学部腫瘍・血液内科学分野（兵庫県）
関西医科大学臨床病理学講座（大阪府）
大阪市立大学癌分子病態制御学、腫瘍外科学（大阪府）
兵庫医科大学臨床遺伝部（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 07 | 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
| 2017 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033819
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| Registered date | File name |
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