UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050729 |
|---|---|
| Receipt number | R000057771 |
| Scientific Title | Whole genome analysis in patients with resected non-small cell lung cancer (WJOG16622L) |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/07/10 15:36:03 |
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Basic information
Public title
Whole genome analysis in patients with resected non-small cell lung cancer (WJOG16622L)
Acronym
Whole genome analysis for non-small cell lung cancer (WJOG16622L)
Scientific Title
Whole genome analysis in patients with resected non-small cell lung cancer (WJOG16622L)
Scientific Title:Acronym
Whole genome analysis for non-small cell lung cancer (WJOG16622L)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore new biomarkers for PD-1/PD-L1 antibody or osimertinib as postoperative adjuvant therapy in patients with resected non-small cell lung cancer using whole genome analysis and RNA sequencing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed non-small cell lung cancer.
(In the osimertinib cohort, with proven EGFR gene mutations.)
2) Frozen specimens (about 5 mm square) of tumor tissue that can be analyzed for whole genome analysis are stored.
3) Pulmonary resection for curative intent has been performed and the diagnosis of pathological stage II-III (TNM classification (UICC 8th edition))
4) 18 years or older.
5) Performance status (ECOG) of 0-2.
6) With a plan to receive osimertinib or PD-1/PD-L1 inhibitors as postoperative adjuvant treatment.
[Osimertinib cohort] patients will receive or has already started the treatment with osimertinib.
[ICI cohort] patients will receive or has already started the treatment with PD-1/PD-L1 inhibitors.
7) Written informed consent concerning study participation
Key exclusion criteria
1) Localized or systemically active infection requiring treatment.
2) Pregnant women, lactating women, women who may be currently pregnant, or cases of unwillingness to use contraception.
3) Clinically problematic psychiatric disorders precluding enrollment.
4) Requirement of continuous systemic administration of steroid, and the current use of an immunosuppressant.
5) History of severe hypersensitivity
6) History of interstitial lung disease, drug-induced interstitial lung disease, idiopathic pulmonary fibrosis, radiation pneumonitis requiring steroid therapy, or active interstitial lung disease.
7) Others judged by the investigator to be unsuitable for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kenmotsu |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-0942
Address
1007 Shimonagakubo, Nagaizumicho, Sunto-gun, Shizuoka, 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 556-0016 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
The Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center Ethical Review Board for Clinical Studies
Address
1007 Shimonagakubo, Nagaizumicho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
rinsho_office@scchr.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
| 2023 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Postoperative adjuvant therapy with PD-1/PD-L1 antibody or osimertinib has been a new standard treatment in patients with resected non-small cell lung cancer. Whole genome analysis has a possibility to explore new biomarkers.
Management information
Registered date
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057771
