UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041957 |
|---|---|
| Receipt number | R000047857 |
| Scientific Title | Lung Cancer Genomic Screening Project for Individualized Medicine Molecular Testing for Resistant Tumors to Systemic Therapy |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2020/09/30 18:25:55 |
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Basic information
Public title
Lung Cancer Genomic Screening Project for
Individualized Medicine Molecular Testing for Resistant Tumors to Systemic Therapy
Acronym
LC-SCRUM-TRY
Scientific Title
Lung Cancer Genomic Screening Project for
Individualized Medicine Molecular Testing for
Resistant Tumors to Systemic Therapy
Scientific Title:Acronym
LC-SCRUM-TRY
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
To characterize the clinicopathological and molecular biological features of lung cancer with specific resistant gene alterations identified in the genomic screening.
Basic objectives2
Others
Basic objectives -Others
To promote the development of novel target therapies and diagnostics through genome screening.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To characterize the clinicopathological and molecular biological features of lung cancer with genetic alterations identified in the genomic screening.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 16 years or older
2)Patients with pathologically (histology or cytology) confirmed non-small cell lung cancer (NSCLC)
3)Patients who have received one or more drug regimens for lung cancer. Patients with treatment-naive NSCLC can be enrolled if blood sample is submitted. (Preoperative/postoperative adjuvant chemotherapy is not included in the calculation of the number of regimens. Chemoradiotherapy is included in the calculation of the number of regimens.)
4)Eastern Cooperative Oncology Group performance status (PS) of 0 or 2
5)Patients who are expected to live for at least 3 months from the date of study enrollment
6)Patients who are able to submit samples that can be used for genetic analyses.
7)Patients who consider to enroll in genotype-directed clinical trials if the target gene alterations are identified in this study
8)Patients who have provided written consent to enroll in this study
Key exclusion criteria
none
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
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 | Hiroki |
| Middle name | |
| Last name | Izumi |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
hiroizum@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited,
Shanghai Haihe Pharmaceutical Co., Ltd.
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
National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
irst@ml.res.ncc.go.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 | 09 | Month | 30 | 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
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
The patients could be enrolled after September 28, 2020, at institutions that have received approval for their institutional ethics review of this study, if they meet the eligibility criteria.
The tumor or blood samples obtained from the patients will be analyzed by next generation sequencing.
Management information
Registered date
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047857
| Research Plan | |
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| 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 |
