UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038679 |
|---|---|
| Receipt number | R000044088 |
| Scientific Title | Clinical performance study of gene mutation test |
| Date of disclosure of the study information | 2019/11/25 |
| Last modified on | 2021/02/15 14:44:51 |
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Basic information
Public title
A feasibility study of performance of a novel method for gene mutations in circulating tumor DNA
Acronym
Clinical performance of a novel method for gene mutations in circulating tumor DNA
Scientific Title
Clinical performance study of gene mutation test
Scientific Title:Acronym
Clinical performance study of gene mutation test
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility verification of EGFR T790M mutation detection using the Digital ICA system, a microfluidic device
Basic objectives2
Others
Basic objectives -Others
Feasibility verification of EGFR T790M mutation detection using the Digital ICA system, a microfluidic device
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quantification of mutant allele and minimum detection limit
Key secondary outcomes
1) Calculation of backgroud noise
2) Seach for cut-off value
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
1) Cell free DNA samples collected in WJOG8014LTR study
2) Residual samples with informed consent that are stocked in WJOG-BBC (Bio-bank Center, West Japan Oncology Group,)
3) Ten samples (20 ng or more DNA) with EGFR T790M positive and other ten samples with EGFR T790M negative detected by the QX100 Droplet Digital PCR system (ddPCR)
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Nishio |
Organization
Kindai University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama
TEL
81-72-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Sakai |
Organization
Kindai University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama
TEL
81-72-366-0221
Homepage URL
kasakai@med.kindai.ac.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Toppan Printing Co., Ltd
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
Institutional Review Board, Kindai University Faculty of Medicine
Address
377-2 Ohno-higashi, Osaka-sayama
Tel
81-72-366-0221
zizen@med.kindai.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
| 2019 | Year | 11 | 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
10
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
| 2018 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044088
