UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017581 |
|---|---|
| Receipt number | R000020376 |
| Scientific Title | Quantitative followup study of the driver mutation fraction in cell-free DNA from non small cell lung cancer patient during TKI therapy |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2020/11/20 17:01:43 |
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Basic information
Public title
Quantitative followup study of the driver mutation fraction in cell-free DNA from non small cell lung cancer patient during TKI therapy
Acronym
Quantitative followup study of the driver gene mutation in cell-free DNA
Scientific Title
Quantitative followup study of the driver mutation fraction in cell-free DNA from non small cell lung cancer patient during TKI therapy
Scientific Title:Acronym
Quantitative followup study of the driver gene mutation in cell-free DNA
Region
| Japan |
Condition
Condition
Non-small cell lung cancer harboring driver mutation.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate clinical benefit of quantitative evaluation of driver mutation by digital PCR, from peripheral circulating free DNA (tumor-specific circulating cell-free DNA: cfDNA) in patients with driver gene mutation non-small-cell lung cancer during treatment with tyrosine kinase inhibitor (TKI).
Basic objectives2
Others
Basic objectives -Others
Clinical benefit of cfDNA analysis with digital PCR.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the quantitative analysis using of EGFR mutation sensitive mutation and T790M mutation in the cfDNA of NSCLC patients who were treated with the conventional EGFR-TKI.
To evaluate the quantitative analysis using of driver mutation (i.e. ALK/RET/ROS1 fusion)and resistant mutation in the cfDNA of NSCLC patients who were treated with the TKIs.
Key secondary outcomes
To evaluate treatment benefit and acquiring resistance from change of fraction of sensitivity mutation and resistant mutation.
To evaluate the concordance between the amount of cfDNA and clinical course.
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
1)Patients with driver gene mutation (i.e. EGFR/ALK/RET/ROS1) -positive non-small-cell lung cancer determined with a histological diagnosis or cytodiagnosis.
2)Patients with treatment plan of EGFR-TKI therapy.
3)Patients with more than 20 years.
4)Patients providing written informed consent.
Key exclusion criteria
1)Patient who need other anti-malignant medicine, radiotherapy or immunity.
2)Patient with positive HBs antigen and HBV-DNA.
3)Patient with definite positive HIV antibody (need not for examination).
4)Patient with other active cancer (except cancer treated without recurrence in more than 5 years and after carcinoma complete excision in situ)
5)TPatient with interstitial pneumonia
6)Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidehito |
| Middle name | |
| Last name | Horinouchi |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
0335422511
hhorinou@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Seki |
Organization
National Cancer Center Research Institute
Division name
Division of genome biology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
0335422511
Homepage URL
yoseki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Oncology, National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Institute
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
Tel
0335422511
NCC_IRBoffice@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）/ National Cancer Center Hospital（Japan）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.myschedule.jp/jsmo2015/search/detail_session/id:149
Number of participants that the trial has enrolled
39
Results
Methods: 33 cfDNA samples from patients who received EGFR-TKI therapy for tumor with sensitive mutations were subjected to a pdPCR-based examination of the proportion of sensitive mutant cfDNAs with the T790M mutation.
Results: sensitive mutations were detected in all 8 samples obtained after acquisition of resistance to TKIs and T790M mutation were positive in 5 of the samples.
Conclusions: pdPCR-based examination of cfDNAs represents a robust non-invasive assessment of tumor progression status.
Results date posted
| 2019 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 01 | Month | 14 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Protocol revision is approved by institutional review board in institution.
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020376
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/11/16 | 修正版＿EGFR変異の定量的追跡試験実施計画書.ver.1.4.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
