UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014782 |
|---|---|
| Receipt number | R000017177 |
| Scientific Title | Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer |
| Date of disclosure of the study information | 2014/08/10 |
| Last modified on | 2024/02/12 20:27:03 |
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Basic information
Public title
Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Acronym
Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Scientific Title
Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Scientific Title:Acronym
Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To detect actionable alterations leading to clinical benefit of targeted therapies in lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assessed the percentage of patients with additional therapy options uncovered by detecting potentially actionable genetic alterations.
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
(i) Histologically confirmed diagnosis of lung cancer
(ii) patient provided written informed consent to conduct genomic studies in accordance with the Institutional Review Board of Kinki University.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakagawa |
Organization
Kinki University
Division name
Medical oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama
TEL
072-366-0221
takedamasa2004@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Takeda |
Organization
Kinki University
Division name
Medical oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama
TEL
072-366-0221
Homepage URL
takedamasa2004@yahoo.co.jp
Sponsor or person
Institute
Kinki University
Institute
Department
Personal name
Funding Source
Organization
Kinki University
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
Kindai university
Address
377-2 Ohno-higashi, Osaka-Sayama
Tel
0723660221
takedamasa2004@yahoo.co.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
| 2014 | Year | 08 | Month | 10 | 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
234
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The percentage of patients with additional therapy options uncovered by detecting potentially actionable genetic alterations, and who actually received genotype-directed therapy based on their genetic testing results, and the success rate of the assay was caluculated, if target sample was enrolled.
Management information
Registered date
| 2014 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017177
