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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018656
Receipt No. R000021602
Scientific Title Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in small cell lung cancer harboring rare gene alterations including PI3K/AKT/mTOR pathway mutations (LC-SCRUM-Japan-SCLC)
Date of disclosure of the study information 2015/08/12
Last modified on 2021/02/24

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Basic information
Public title Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in small cell lung cancer harboring rare gene alterations including PI3K/AKT/mTOR pathway mutations (LC-SCRUM-Japan-SCLC)
Acronym LC-SCRUM-Japan-SCLC
Scientific Title Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in small cell lung cancer harboring rare gene alterations including PI3K/AKT/mTOR pathway mutations (LC-SCRUM-Japan-SCLC)
Scientific Title:Acronym LC-SCRUM-Japan-SCLC
Region
Japan

Condition
Condition Small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clarify small cell lung cancer harboring PI3K/AKT/mTOR pathway mutations and characterize its clinicopathological and molecular feature
Basic objectives2 Others
Basic objectives -Others To evaluate the frequencies and characteristics of any cancer-related gene alterations in small cell lung cancer using OCP (Cancer Panel)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To clarify the clinicopathological and molecular feature in small cell lung cancer harboring PI3K/AKT/mTOR pathway mutations
Key secondary outcomes To evaluate the frequencies and characteristics of any cancer-related gene alterations in small cell lung cancer using OCP (Cancer Panel)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically or cytologically confirmed small cell lung cancer
2.Chemotherapy is planned
3.ECOG performance status of 0 to 2
4.Adequate organ function (Correspond to the following values in laboratory tests performed within 14 days before registration)
a.Neutrophil count >= 1,500/mm3
b.Hemoglobin >= 8.0g/dL
c.Platelet count >= 75,000/mm3
d.AST,ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST,ALT: <= ULNx5.0)
e.Total bilirubin: <= ULNx1.5
5.No serious comorbidities (for example: interstitial pneumonia, or uncontrolled diabetes mellitus, heart disease or infection)
6.Life expectancy of at least 3 months
7.Samples suitable for genomic analysis
8.Intention to register clinical trials
9.Written informed consent
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Goto
Middle name
Last name Goto
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code 2778577
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 Koichi
Middle name
Last name Goto
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code 2778577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email kgoto@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1 Tsukiji, Chuo-ku Tokyo
Tel 03-3542-2511
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
2015 Year 08 Month 12 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 1035
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 No longer recruiting
Date of protocol fixation
2015 Year 05 Month 27 Day
Date of IRB
2015 Year 05 Month 27 Day
Anticipated trial start date
2015 Year 07 Month 03 Day
Last follow-up date
2022 Year 05 Month 26 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
2015 Year 08 Month 12 Day
Last modified on
2021 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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