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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030313
Receipt No. R000034595
Scientific Title Prognostic factors of non-small cell lung cancer patients with brain metastasis
Date of disclosure of the study information 2017/12/08
Last modified on 2020/02/25

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Basic information
Public title Prognostic factors of non-small cell lung cancer patients with brain metastasis
Acronym Prognostic factors of non-small cell lung cancer patients with brain metastasis
Scientific Title Prognostic factors of non-small cell lung cancer patients with brain metastasis
Scientific Title:Acronym Prognostic factors of non-small cell lung cancer patients with brain metastasis
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the benefits of treatment for brain metastases in non-small cell cancer patients and to investigate the prognostic factors in those patients
Basic objectives2 Others
Basic objectives -Others Retrospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the prognosis in non-small cell lung cancer patients with brain metastasis and investigate the prognostic factors in those patients
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with histologically confirme non-small cell lung cancer with brain metastasis at the point of diagnosis or recurrence in Hokkaido Lung Cancer Clinical Study Group (HOT) and cooperation hospitals from January 2008 through December 2014.
Key exclusion criteria 1) Histologically undiagnosed disease
2) Unable to get the clincal information from medical records
3) The cases of recurrence in brain metastasis after chemoradiotherapy
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Kojima
Organization KKR Sapporo Medical Center
Division name Department of Medical Oncology
Zip code 062-0831
Address 1-jou 6-chome, Hiragishi, Toyohira-ku, Sapporo
TEL 011-822-1811
Email kotetsu@kkr-smc.com

Public contact
Name of contact person
1st name Yoshihito
Middle name
Last name Ohhara
Organization Hokkaido University Hospital
Division name Department of Medical Oncology
Zip code 060-8638
Address West 5, North 14, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email yoshihito_ohhara@yahoo.co.jp

Sponsor
Institute KKR Sapporo Medical Center
Institute
Department

Funding Source
Organization KKR Sapporo Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization KKR Sapporo Medical Center
Address 1-jou 6-chome, Hiragishi, Toyohira-ku, Sapporo
Tel 011-822-1811
Email kotetsu@kkr-smc.com

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
2017 Year 12 Month 08 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 Completed
Date of protocol fixation
2017 Year 11 Month 21 Day
Date of IRB
2017 Year 11 Month 22 Day
Anticipated trial start date
2017 Year 11 Month 22 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Age
2.Sex
3.date of diagnosis
4.ECOG performance status
5.smoking history
6.Clinical staging
7.metastatic sites
8.histological type
9.EGFR gene mutation
10.ALK fusion gene
11.date of diagnosis of brain metastasis
12.diagnostic devices of brain metastasis (CT/MRI)
13.location of brain metastasis
14.number of brain metastasis
15.longest diameter of brain metastasis
16.sum of diameters of brain metastases
17.symptons related with brain metastasis
18.brain edema
19.Meninges dissemination
20.Local treatmetent for brain metastases
21.Whole brain irradiation
22.local radiation therapy for brain metastases
23.surgery for brain metastases
24.dementia
25.systemic chemotherapy
26.total number of regimens
27.chemotherapy regimens
28.VEGF inhibitor
29.EGFR-TKI
30.ALK inhibitor
31.Immuno checkpoint inhibitor
32.clinical outcome, date of death, last follow-up date

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2020 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034595

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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