UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA
Title of the study (Brief title)	LC-SCRUM-Liquid
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this research is to verify the effectiveness of multiplex genetic analysis by means of a next-generation sequencer using cell free DNA (cfDNA) derived from lung cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Concordance of Guardant360 data for ctDNA and NGS data for tumor samples by Oncomine Comprehensive Assay (OCA)
Key secondary outcomes	1.The percentage of patients observed to have alterations to the 7 driver genes (EGFR, ALK, ROS1, BRAF, MET, RET, ERBB2). 2.Clinical efficacy (response rate, time to treatment failure, overall survival period) of molecular-targeted therapy in patients in whom genetic alterations are detected by Guardant360. 3.Time course of molecular profiling change which are related with drug resistance.

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. 20 years old or above 2. Pathologically confirmed non-small cell lung cancer (regardless of histology or cytology) 3. Clinical stage III, stage IV or postsurgical relapse at the time of registration. 4. The disease is inoperable and ineligible for radical radiation therapy, and chemotherapy is planned. 5. The subject is chemotherapy naive or had a history of chemotherapy of no more than 2 regimens. 6. Enrollment in a prospective observational study to clarify the clinicopathological and molecular biological features of lung cancer with low-frequency genetic changes, such as the RET fusion gene, in non-small cell lung cancer. 7. The patient who can provide blood sample within 4 weeks of tumor sample collection. The patient is going to be excluded if prescribed blood sample cannot be collected. 8. With written informed consent.
Key exclusion criteria	None
Target sample size	2000

Research contact person
Name of lead principal investigator	Koichi Goto
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Email	kgoto@east.ncc.go.jp

Public contact
Name of contact person	Yuko Usui, Shigeki Umemura, Koichi Goto
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Homepage URL
Email	sumemura@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Guardant Health
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	国立研究開発法人国立がん研究センター東病院

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 07 Day
Anticipated trial start date	2017 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is a prospective observational study.

Management information
Registered date	2017 Year 12 Month 20 Day
Last modified on	2017 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034795