UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Circulating tumor cells for EGFR-TKI resistance in NSCLC patients; prospective, multicenter study
Title of the study (Brief title)	CTC for EGFR-TKI resistance in NSCLC
Region	Japan

Condition
Condition	Non small cell lung carcinoma with EGFR mutation
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To detect the EGFR-TKI resistance using circulating tumor cells.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The frequency of detecting T790M in CTC
Key secondary outcomes

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.NSCLC with EGFR mutation(Ex.18,19,21) 2.Kick off the Gefitinib 3.Having the detectable taget (>10mm) 4.Getting the informed consent
Key exclusion criteria	1. HIV, HBV, HCV 2. History of Gefitinib, Erlotinib and crizotinib 3. Symptomatic brain metastasis 4. Presence of pulmonary fibrosis or interstitial pneumonia in chest CT 5. Active double cancer 6. Primary physician considered not to be suitable for the study.
Target sample size	30

Research contact person
Name of lead principal investigator	Noriyuki Matsutani
Organization	Teikyo University School of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo
TEL	03-3964-1231
Email	matsutan@med.teikyo-u.ac.jp

Public contact
Name of contact person	Noriyuki Matsutani
Organization	Teikyo University School of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo, Japan
TEL	03-3964-1231
Homepage URL
Email	matsutan@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo university school of medicine
Institute
Department

Funding Source
Organization	Teikyo university school of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nihon University Tokyo Metropolitan Geriatric Hospital
Name of secondary funｄer(s)

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	帝京大学（東京都） 日本大学（東京都） 東京都健康長寿医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 03 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 08 Month 12 Day
Anticipated trial start date	2014 Year 12 Month 03 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Chest CT, tumor marker and sample blood for each 3 month

Management information
Registered date	2014 Year 12 Month 03 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018417