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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023248
Receipt No. R000026708
Scientific Title Investigation on the usefulness of liquid biopsy for tumor-derived circulating DNA in patients with EGFR-mutant NSCLC during and after treatment with EGFR-TKIs
Date of disclosure of the study information 2016/07/20
Last modified on 2019/01/09

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Basic information
Public title Investigation on the usefulness of liquid biopsy for tumor-derived circulating DNA in patients with EGFR-mutant NSCLC during and after treatment with EGFR-TKIs
Acronym JP-CLEAR
(Japanese Prospective evaluation of tumor-derived Circulating DNA Liquid biopsy in patients with EGFR-mutant NSCLC during and after Acquired Resistance to EGFR-TKI treatment)
Scientific Title Investigation on the usefulness of liquid biopsy for tumor-derived circulating DNA in patients with EGFR-mutant NSCLC during and after treatment with EGFR-TKIs
Scientific Title:Acronym JP-CLEAR
(Japanese Prospective evaluation of tumor-derived Circulating DNA Liquid biopsy in patients with EGFR-mutant NSCLC during and after Acquired Resistance to EGFR-TKI treatment)
Region
Japan

Condition
Condition Non-small cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the diagnostic value of plasma ctDNA of EGFR mutations in the trajectory of patients with EGFR activating mutation-positive non-small cell lung cancer(NSCLC)treated with EGFR-TKIs , including a third-generation TKI
Basic objectives2 Others
Basic objectives -Others Diagnostic value
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes *The plasma DNA T790M positivity rates by Cobas EGFR Mutation Test in the T790M positive tumors patients.
*The plasma DNA T790M positivity rates at each clinical point.
Key secondary outcomes *The plasma DNA EGFR Exon 19 deletion or Exon 21 L858 mutation positivety rates in clinical courses
*Time from plasma T790 positivity to tissue T790M positivity in the tissue T790M-positive cases
*Response Rate and PFS with Osimertinib
*Response Rate and PFS with rechallenge of other EGFR-TKIs

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)Patients diagnosed as having advanced or postoperative recurrent NSCLC prior to enrollment
2)Patients diagnosed as carrying activating EGFR mutation by each institution (exon19 deletion, exon 21 L858R mutation, or other minor mutations such as exon 18 G719X)
3)Those being treated without progression, or to be treated with, an EGFR-TKI as anticancer therapy
4)ECOG PS 0-2
5)20 years old over
6)Submitted signed informed consent
Key exclusion criteria 1)Prior treatment with EGFR-TKI
2)HBsAg or HCV-RNA positive Patients
3)HIV positive Patients

Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Kunitoh
Organization Japanese Red Cross Medical Center
Division name Department of Medical Oncology
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL 03-3400-1311
Email kunito-hideo@med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamao
Organization Public Health Reseach Foundation
Division name Comprehensive Support Project for Oncology Research
Zip code
Address 1-1-7 Nishi-waseda,Shinjuku-ku,Tokyo
TEL 03-5287-2636
Homepage URL
Email cspor-lc05@csp.or.jp

Sponsor
Institute PHRF
Institute
Department

Funding Source
Organization Astra Zeneca K K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor No
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岩手県立中央病院(岩手県)、群馬県立がんセンター(群馬県)、国立病院機構 渋川医療センター(群馬県)、春日部市立医療センター(埼玉県)、さいたま赤十字病院(埼玉県)、杏林大学医学部付属病院(東京都)、国立研究開発法人 国立国際医療研究センター病院(東京都)、昭和大学病院(東京都)、虎の門病院(東京都)、日本赤十字社医療センター(東京都)、NTT東日本関東病院(東京都)、社会福祉法人 三井記念病院(東京都)、昭和大学藤が丘病院(神奈川県)、藤沢市民病院(神奈川県)、関西電力病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 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
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 07 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All patients who has given consent to participate in the study during from 2016/08/01 to 2017/3/31

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026708

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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