UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014448 |
|---|---|
| Receipt number | R000016809 |
| Scientific Title | Establishment of cell lines from tumors of respiratory system and evaluation of genetic mutations |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2020/01/08 14:09:03 |
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Basic information
Public title
Establishment of cell lines from tumors of respiratory system and evaluation of genetic mutations
Acronym
Establishment of cell lines from tumors of respiratory system and evaluation of genetic mutations
Scientific Title
Establishment of cell lines from tumors of respiratory system and evaluation of genetic mutations
Scientific Title:Acronym
Establishment of cell lines from tumors of respiratory system and evaluation of genetic mutations
Region
| Japan |
Condition
Condition
Tumors of respiratory system
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish cell lines from clinically obtained samples of respiratory system tumors using irradiated fibroblasts and ROCK inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the success rate of establishing cell lines from clinically obtained samples of respiratory system tumors.
Key secondary outcomes
If cell lines are established, the genetic mutations will be examined to assess the relevance.
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
a) Age >= 20 years.
b) Patients must provide written, informed consent before any study procedures occur.
c) Family of the deceased must provide written informed consent for the use of autopsy samples.
Key exclusion criteria
Patients whom principal investigator considers as unsuitable.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Eiki |
| Middle name | |
| Last name | Kikuchi |
Organization
Hokkaido University Hospital
Division name
First Department of Medicine
Zip code
0608648
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
(011)706-5911
eikik@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Eiki |
| Middle name | |
| Last name | Kikuchi |
Organization
Hokkaido University Hospital
Division name
First Department of Medicine
Zip code
0608648
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
(011)706-5911
Homepage URL
eikik@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Hokkaido University Hospital
Address
N 14, W 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
(011)706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
90
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
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observation analysis (exploratory analysis of clinical samples)
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016809
