UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030496 |
|---|---|
| Receipt number | 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 20:39:11 |
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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
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
sumemura@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
