UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030496
Receipt No. R000034795
Scientific Title A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA
Date of disclosure of the study information 2017/12/25
Last modified on 2017/12/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA
Acronym LC-SCRUM-Liquid
Scientific Title A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA
Scientific Title:Acronym 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
1st name
Middle name
Last name Koichi Goto
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email kgoto@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Usui, Shigeki Umemura, Koichi Goto
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
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)

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 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

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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.