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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041583
Receipt No. R000047417
Scientific Title A prospective observational study to evaluate the detection rate of actionable mutations by liquid biopsy Guardant360 in patients with non-squamous non-small cell lung cancer (NSCLC) whose gene alterations are not detected by tissue-based singleplex assays. (WJOG13620L)
Date of disclosure of the study information 2020/08/31
Last modified on 2020/10/17

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Basic information
Public title A prospective observational study to evaluate the detection rate of actionable mutations by liquid biopsy Guardant360 in patients with non-squamous non-small cell lung cancer (NSCLC) whose gene alterations are not detected by tissue-based singleplex assays. (WJOG13620L)
Acronym A prospective observational study by G360 in NSCLC patients whose gene alterations are not detected by tissue-based singleplex assays. (WJOG13620L)
Scientific Title A prospective observational study to evaluate the detection rate of actionable mutations by liquid biopsy Guardant360 in patients with non-squamous non-small cell lung cancer (NSCLC) whose gene alterations are not detected by tissue-based singleplex assays. (WJOG13620L)
Scientific Title:Acronym A prospective observational study by G360 in NSCLC patients whose gene alterations are not deteted by tissue-based singleplex assays. (WJOG13620L)
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To examine the detection rate of major genomic alterations by Guardant360 in patients whose gene alterations are not detected by tissue-based singleplex assays with Stage 3B-4 and recurrent non-squamous NSCLC that is inoperable and chemoradiation therapy ineligible.
Basic objectives2 Others
Basic objectives -Others The detection rate of major genomic alterations
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of major actionable genomic alterations in 8 genes (EGFR (exon 18-21 indel or point mutation), ALK fusion, ROS1 fusion, BRAF (exon 15 V600E point mutation), MET exon 14 skipping, RET fusion, ERBB2 exon 20 insertion, KRAS (exon 2-3 point mutation), NTRK fusion) by Guardant360.
Key secondary outcomes Detection rate of each 9 genomic alteration by Guardant360, rate of the patient whose gene alterations are detected by companion diagnostics based on the result of Guardant360, rate of the patient treated with molecular-targeted drugs, and turn-around time

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) Histologically confirmed non-squamous NSCLC.
2) Stage 3B-4 and recurrent non-squamous NSCLC that is inoperable and chemoradiation therapy ineligible.
3) Men and women above 20.
4) EGFR gene is confirmed as wild type by a singleplex assay. The results of the other 7 genes tested are unknown or negative at the time of enrollment.
5) Comprehensive genomic profiling such as OncomineTM Dx Target Test, OncoGuideTM NCC Oncopanel System, and FoundationOne(R) CDx has not been examined.
6) No prior treatment with cytotoxic agent/molecular targeted therapy/ immune checkpoint inhibitor for advanced stage NSCLC (recurrence after postoperative adjuvant chemotherapy or chemoradiotherapy finished can be registered).
7) Treatable with anti-cancer drugs. Life expectancy >= 3 months.
8) Written informed consent after sufficient explanation.
Key exclusion criteria 1) Multiple cancer with metastasis.
2) Severe psychological disease.
3) Not fit for this trial judged by the doctor in charge.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Hirotsugu
Middle name
Last name Kenmotsu
Organization Shizuoka Cancer Center
Division name Thoracic Oncology
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture, Japan.
TEL 055-989-5222
Email h.kenmotsu@scchr.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code 556-0016
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization Guardant Health Japan Corp.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya City University Hospital
Address 1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8602
Tel 052-851-5511
Email t50uemu@med.nagoya-cu.ac.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 28 Day
Last follow-up date
2023 Year 01 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 08 Month 28 Day
Last modified on
2020 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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