UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035628 |
|---|---|
| Receipt number | R000040587 |
| Scientific Title | Monitoring study of genomic mutations in patients with EGFR mutation or ALK translocation using plasma DNA |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2023/07/28 19:07:14 |
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Basic information
Public title
Monitoring study of genomic mutations in patients with EGFR mutation or ALK translocation using plasma DNA
Acronym
Monitoring of genomic mutations using plasma DNA
Scientific Title
Monitoring study of genomic mutations in patients with EGFR mutation or ALK translocation using plasma DNA
Scientific Title:Acronym
Monitoring of genomic mutations using plasma DNA
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To address the association of the plasma DNA genotyping and treatment efficacy
Basic objectives2
Others
Basic objectives -Others
Exploratory study of the genomic mutations relevant to drug resistance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of significance of the monitoring the genomic mutations using the circulating tumor DNA
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
Advanced non-small-cell lung cancer patients harboring EGFR mutation or ALK translocation
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Koh |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8509
Address
811-1 Kimiidera Wakayama
TEL
073-441-0619
ykoh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Koh |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8509
Address
811-1 Kimiidera Wakayama
TEL
073-441-0619
Homepage URL
ykoh@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Wakayama Medical University
Address
8-1-1 Kimiidera, Wakayama
Tel
0734410619
wa-rinri@wakayama-med.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 | 01 | Month | 23 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
100
Results
Plasma DNAs were collected from patietns with non-small cell lung cancer harboring EGFR mutations or ALK rearrangement. Paired samples such as at baseline and at progressive disease were collected. Next generation sequencing was performed to detect cancer-related somatic mutations using the plasma DNA including EGFR mutations and ALK rearrangement. We were able to track the changes in the variant allele frequency of those genes and identify the potential gene mutations responsible for drug resistance.
Results date posted
| 2023 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Non-small cell lung cancer harboring EGFR mutations or ALK rearrangement
Participant flow
Written informed consent was obtained from non-small lung cancer patients harboring EGFR mutatinos or ALK rearrangement after the explanation about the study.
Adverse events
Nothing severe
Outcome measures
We were able to track the changes in the variant allele frequency of those genes and identify the potential gene mutations responsible for drug resistance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Mutational analyses using the plasma DNA at baseline, 4 weeks and progressive disease will be performed and association with clinical information will be investigated.
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040587
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