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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024198
Receipt No. R000027500
Scientific Title Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI :a prospective observational study
Date of disclosure of the study information 2016/10/01
Last modified on 2019/04/01

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Basic information
Public title Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI :a prospective observational study
Acronym Frequency of T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI
Scientific Title Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI :a prospective observational study
Scientific Title:Acronym Frequency of T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI
Region
Japan

Condition
Condition EGFR-mutated Non Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Analysis of the Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI
Basic objectives2 Others
Basic objectives -Others Evaluation of the relationship between effect of irreversible EGFR-TKI and T790M mutation status
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI
Key secondary outcomes Evaluation of the relationship between effect of irreversible EGFR-TKI and T790M mutation status

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 whose plasma samples can be submitted
2 Pathologically confirmed Nonsquamous Non Small Cell Lung Cancer
3 Clinical stage 3B, 4, or postoperative recurrence
4 With activating EGFR mutation, Deletion in exon 19 or L858R in exon 21
5 Patients with no treatment of EGFR-TKI and planned to EGFR-TKI treatment
6 Regarding the patients who have be treated with radiotherapy
-Not have received radiotherapy to lesions of lung
-More than 12 weeks after receiving radiotherapy to Sternal lesions
-More than 2 weeks after receiving radiotherapy to lesions except lung
7 Regarding the patients who have been treated with therapy as follows
-Surgical procedure, including exploratory thoracotomy, more than 4 weeks
-Pleural drainage, more than 2 weeks
-Pleurodesis except anticancer drugs, more than 2 weeks
-AnticancerDrugs, more than 3 weeks
8 Performance Status (ECOG) 0-2
9 Expecte survival time is more than 3 months
10 With adequate organ function
11 Provided written informed consent
12 Ages 20 years and over
Key exclusion criteria 1 Patients with pre-treatment of EGFR-TKI
2 Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest X-ray
3 Synchronous double or multiple cancer or metachronous double or multiple cancer
4 Uncontrolled pleural, ascites effusion or cardiac effusion
5 Patients with active co-morbidities including severe conditions.
-Uncontrollable angina pectoris, myocardial infarction within 3 months, heart failure
-Uncontrolled diabetes mellitus, hypertension
-Severe infection
-Patients whose participation in the trial is judged to be inappropriate by the attending doctor
-Any other patients who are regarded as unsuitable for this trial by the attending doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Nobuaki
Middle name
Last name Kobayashi
Organization Graduate school of medicine, Yokohama city university
Division name department of pulmonology
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, JAPAN
TEL 045-787-2508
Email nkobayas@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Nagakura
Organization Graduate school of medicine, Yokohama city university
Division name department of pulmonology
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, JAPAN
TEL 045-787-2508
Homepage URL
Email hdng8315@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim 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 Yokohama City University Ethics Committee
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
Tel 045-370-7627
Email rinri@yokohama-cu.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 横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 30
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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 24 Day
Date of IRB
2016 Year 08 Month 24 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 09 Month 30 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information Study design:
Prospective cohort study
Object recruitment:
From October 2016 to June 2018, all patients who visit our facility and meet the inclusion criteria from October 2015 to September 2017.
Parameter measurement:
#1 T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI before treatment, under treatment and disease progression
#2 Evaluation of the relationship between effect of irreversible EGFR-TKI and T790M mutation status

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027500

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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