UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003924 |
|---|---|
| Receipt number | 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 18:50:34 |
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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
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
Sponsor or person
Institute
Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.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 |
