UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016607 |
|---|---|
| Receipt number | 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 19:48:32 |
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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
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
esugiyam@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019273
