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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017581
Receipt No. 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

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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
Email 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
Email yoseki@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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