UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016727 |
|---|---|
| Receipt number | R000019408 |
| Scientific Title | Effectiveness of Liquid Based Cytology (LBC) for Genetic Testing on Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2020/09/10 07:57:51 |
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Basic information
Public title
Effectiveness of Liquid Based Cytology (LBC) for Genetic Testing on Non-Small-Cell Lung Cancer
Acronym
Effectiveness of Liquid Based Cytology (LBC) for Genetic Testing on Non-Small-Cell Lung Cancer
Scientific Title
Effectiveness of Liquid Based Cytology (LBC) for Genetic Testing on Non-Small-Cell Lung Cancer
Scientific Title:Acronym
Effectiveness of Liquid Based Cytology (LBC) for Genetic Testing on Non-Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Primary non-small-cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of LBC for genetic testing on non-small-cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of genetic testing between FFPE and LBC
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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)Previously untreated non-small-lung cancer patients
(2)The patients who are diagnosed as non-small-lung cancer before/during surgical operation
(3)Regardless of age, gender, inpatient admission or outpatient
(4)Written informed consent
Key exclusion criteria
(1)Small cell lung cancer patients
(2)In case written informed consent is not obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Satoh |
Organization
Kitasato University
Division name
Department of Thoracic Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0374, Japan
TEL
042-778-8828
ysatoh@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Satoh |
Organization
Kitasato University
Division name
Department of Thoracic Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0374, Japan
TEL
042-778-8828
Homepage URL
ysatoh@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Kitasato University Medical Ethics Organization
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-7756
rinrib@med.kitasato-u.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 25 | 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
117
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 | 10 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison between LBC and FFPE for Genetic testing on primary Non-Small-Cell Lung Cancer cells: a prospective study.
LBC bring the expected equivalent results of conventional FFPE.
Management information
Registered date
| 2015 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019408
