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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003924
Receipt No. R000004716
Scientific Title An analysis of cytokines for venous thrombosis and pulmonary embolism risk associated with lung cancer
Date of disclosure of the study information 2010/07/17
Last modified on 2012/02/05

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Basic information
Public title An analysis of cytokines for venous thrombosis and pulmonary embolism risk associated with lung cancer
Acronym An analysis of cytokines for venous thrombosis and pulmonary embolism risk associated with lung cancer
Scientific Title An analysis of cytokines for venous thrombosis and pulmonary embolism risk associated with lung cancer
Scientific Title:Acronym An analysis of cytokines for venous thrombosis and pulmonary embolism risk associated with lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate differences of
cytokines between non-small cell
lung cancer with or without
venous thrombosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Incidence of venous thrombosis
and pulmonary embolism.
2) Impact of venous thrombosis
and pulmonary embolism for survival
and treatment.
3) To evaluate immunohistological and
serum cytokines such as VEGF.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven non-small cell lung cancer.
2) Adequate renal function to
receive enhanced CT scans
Key exclusion criteria Inappropriate patients for this study judged by the physicians
Patients can not agree to participate
in this trial.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kszuma Kishi
Organization Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name Department of Respiratory Medicine
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Uruga
Organization Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name Department of Respiratory Medicine
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Institute
Department

Funding Source
Organization None
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
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
2010 Year 07 Month 17 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 Terminated
Date of protocol fixation
2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
2012 Year 01 Month 01 Day
Date trial data considered complete
2012 Year 01 Month 01 Day
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information 1) Incidence of venous thrombosis
and pulmonary embolism
2) Impact of venous thrombosis
and pulmonary embolism for survival
and treatment

Management information
Registered date
2010 Year 07 Month 17 Day
Last modified on
2012 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004716

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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