UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041583 |
|---|---|
| Receipt number | 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 | 2023/01/30 13:25:04 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
72
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 13 | Day |
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
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047417
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