UMIN-CTR Clinical Trial

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
Email	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
Email	hiroizum@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047857