UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031472 |
|---|---|
| Receipt number | R000035922 |
| Scientific Title | Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/02/25 17:39:10 |
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Basic information
Public title
Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Acronym
Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Scientific Title
Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Scientific Title:Acronym
Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of biopsy specimen, circulating tumor cells and cell free DNA
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gene analysis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologically proven lung cancer with EGFR mutation
A re-biopsy was planned within 2 weeks after progression under EGFR-TKI treatment
written informed consent
Key exclusion criteria
inappropriate participation judged by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsunari Hase |
Organization
Nagoya University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
65 tsurumai-cho, showa-ku, nagoya
TEL
052-741-2111
thase@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsunari Hase |
Organization
Nagoya University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
65 tsurumai-cho, showa-ku, nagoya
TEL
052-741-2111
Homepage URL
thase@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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
This study is a prospective observational study.
Management information
Registered date
| 2018 | Year | 02 | Month | 25 | Day |
Last modified on
| 2018 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035922
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
