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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036871
Receipt No. R000042014
Scientific Title Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/28

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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
2021 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
2019 Year 05 Month 28 Day


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

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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