UMIN-CTR Clinical Trial

Basic information
Public title	Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
Acronym	LC-SCRUM-Asia
Scientific Title	Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
Scientific Title:Acronym	LC-SCRUM-Asia
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 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 3) Patients with cancer of clinical stage II or higher, or postoperative recurrence 4) Patients who have not received any drug treatments or have a history of two or less drug regimens for lung cancer (Patients with a history of three or more drug regimens are not eligible. However, preoperative/postoperative adjuvant chemotherapy is not included in the calculation of the number of regimens) 5) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 6) Patients who meet the following criteria for major organ function (assessed by a test performed within 2 weeks prior to study enrollment): i) Neutrophil count : >=1500/mm3 ii) Hemoglobin : >=8.0 g/dl iii) Platelet count : >=7.5 x 104/mm3 iv) AST, ALT : <=ULN (upper limit of normal) x 2.5 (x 5 in patients with liver metastasis) v) Total bilirubin : <=ULN x 1.5 7) Patients without serious complications (e.g., interstitial pneumonitis, poorly controlled diabetes mellitus, cardiac disease, infection, etc.) 8) Patients who are expected to live for at least 3 months from the date of study enrollment 9) Patients who are able to submit samples that can be used for genetic analyses. The samples must be ones collected before the initial drug treatment 10) Patients who wish to enroll in genotype-directed clinical trials if the target gene alterations are identified in this study 11) Patients who have provided written consent to enroll in this study
Key exclusion criteria	none
Target sample size	2500

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 Matsumoto Middle name Last name Shingo
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	shmatsum@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
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	National Cancer Center Hospital East
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel	04-7133-111
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	2019 Year 06 Month 01 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	2019 Year 03 Month 12 Day
Date of IRB	2019 Year 03 Month 28 Day
Anticipated trial start date	2019 Year 06 Month 10 Day
Last follow-up date	2041 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a prospective observational study.

Management information
Registered date	2019 Year 05 Month 28 Day
Last modified on	2022 Year 05 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042014