UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003179 |
|---|---|
| Receipt number | R000003277 |
| Scientific Title | Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2014/10/27 08:10:42 |
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Basic information
Public title
Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Acronym
Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Scientific Title
Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Scientific Title:Acronym
Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
to detect gene and gene aberrations associated with malignancy, prognosis and treatment response by analysis of correlation between genetic aberrations and clinicopathological factors
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
orrelation between genetic aberrations and clinicopathological factors
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
Provision of informed consent and availability of clinical specimens for analysis of lung cancer-related genes.
Key exclusion criteria
Lack of provision of informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Nakamura |
Organization
St. Marianna University School of Medicine
Division name
Department of Chest Surgery
Zip code
Address
Sugao 2-16-1, Miyamae-ku, Kanagawa Kawasaki, Japan
TEL
044-977-8111
h-nakamura@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuo Shimmyo |
Organization
St. Marianna University School of Medicine
Division name
Department of Chest Surgery
Zip code
Address
Sugao-2-16-1, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
t2shinmyo@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Department of Chest Surgery
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine, Department of Chest Surgery
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
聖マリアンナ医科大学 (St. Marianna University School of Medicine)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | 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
We have taken lung samples in 76 cases up to now, which include resected tissue of lung carcinomas about 1g each cases, and cell stamped slide glasses in the -40 degrees freezer. And we succeed in extraction DNA from these 10 cases, and analyzed the EGFR hotspot mutation L858R in exon 21 and in-frame deletion of exon 19 that account for approximately 91% of EGFR kinase domain mutations by LH-MSA(Loop Hybrid-Mobility shift assay) after polymerase chain reaction (PCR). In addition, FISH(fluorescence in situ hybridization) and immunohistochemistory stein using EGFR specific antigen was performed, resulted in detection of EGFR mutation in 4 cases. Further sample collection and analyses will be planned.
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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
Taking samples and registration In progress
Management information
Registered date
| 2010 | Year | 02 | Month | 14 | Day |
Last modified on
| 2014 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
