UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002807 |
|---|---|
| Receipt number | R000003416 |
| Scientific Title | Evaluation of reference interval and cutoff value of ProGRP in serum and plasma |
| Date of disclosure of the study information | 2009/11/27 |
| Last modified on | 2009/11/27 18:32:31 |
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Basic information
Public title
Evaluation of reference interval and cutoff value of ProGRP in serum and plasma
Acronym
Evaluation of reference interval and cutoff value of ProGRP in serum and plasma
Scientific Title
Evaluation of reference interval and cutoff value of ProGRP in serum and plasma
Scientific Title:Acronym
Evaluation of reference interval and cutoff value of ProGRP in serum and plasma
Region
| Japan |
Condition
Condition
small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of reference interval and cutoff value of ProGRP in serum and plasma
Basic objectives2
Others
Basic objectives -Others
Evaluation of reference interval and cutoff value
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reference interval and cutoff value of ProGRP in serum and plasma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Blood draw
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 Small cell lung cancer,non small cell lung cancer, benign respiratory diseases
1) Aged 20 years or older
2) Written informed consent
3) Diagnosed as SCLC or NSCLC cytologically or histologically / diagnosed as benign respiratory diseases
2 Healthy subject
1) Aged 20 years or older
2) Written informed consent
Key exclusion criteria
1 Small cell lung cancer, non small cell lung cancer, benign respiratory diseases
1) Not applicable
2 Healthy subject
1) Abnormal shadow by X rays of chest within a year
2) Abnormal creatinine value
3) Renal disorder
4) Hepatic disorder
Target sample size
1534
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Yamamoto |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777,Japan
TEL
Homepage URL
Sponsor or person
Institute
Pharma Valley Center, the Shizuoka Organization of Creation Industries
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center, the Shizuoka Organization of Creation Industries
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2009 | Year | 11 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 27 | Day |
Last modified on
| 2009 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003416
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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