UMIN-CTR Clinical Trial

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	122
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	Completed
Date of protocol fixation	2016 Year 07 Month 27 Day
Date of IRB	2016 Year 08 Month 05 Day
Anticipated trial start date	2016 Year 08 Month 10 Day
Last follow-up date	2020 Year 03 Month 26 Day
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	2022 Year 07 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026708