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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016607
Receipt No. R000019273
Scientific Title Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in squamous cell lung cancer harboring FGFR alternation (LC-SCRUM-Japan-Sq)
Date of disclosure of the study information 2015/02/23
Last modified on 2016/08/29

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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 squamous cell lung cancer harboring FGFR alternation (LC-SCRUM-Japan-Sq)
Acronym LC-SCRUM-Japan-Sq
Scientific Title Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in squamous cell lung cancer harboring FGFR alternation (LC-SCRUM-Japan-Sq)
Scientific Title:Acronym LC-SCRUM-Japan-Sq
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the clinicopathological and molecular characteristics in squamous cell lung cancer harboring FGFR alternation in nationwide Japanese patients
Basic objectives2 Others
Basic objectives -Others To evaluate the frequencies and characteristics of any cancer-related gene alterations in squamous 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 squamous cell lung cancer harboring FGFR gene alterations
Key secondary outcomes To evaluate the frequencies and characteristics of any cancer-related gene alterations in squamous 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 diagnosis of squamous cell lung cancer
2. Unresectable stage III-IV or postoperative recurrence patients unfitted for definitive hemoradiotherapy
3. Chemotherapy is planned regardless of pre-treatment history
4. Signed informed consent
Key exclusion criteria None
Target sample size 600

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

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Goto, Eri Sugiyama
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1, Kahiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email esugiyam@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization SCRUM-Japan
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
Address
Tel
Email

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 02 Month 23 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
2015 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
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 02 Month 23 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019273

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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