UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015261 |
|---|---|
| Receipt number | R000017745 |
| Scientific Title | Evaluation examination of the standard value and cut-off level of proGRP in blood using the Elecsys proGRP |
| Date of disclosure of the study information | 2014/09/26 |
| Last modified on | 2016/03/28 08:58:20 |
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Basic information
Public title
Evaluation examination of the standard value and cut-off level of proGRP in blood using the Elecsys proGRP
Acronym
Evaluation examination of the standard value and cut-off level of proGRP in blood using the Elecsys proGRP
Scientific Title
Evaluation examination of the standard value and cut-off level of proGRP in blood using the Elecsys proGRP
Scientific Title:Acronym
Evaluation examination of the standard value and cut-off level of proGRP in blood using the Elecsys proGRP
Region
| Japan |
Condition
Condition
Small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Confirmation of the equivalency with other extracorporeal diagnostic agents of the basic performance
2) Setting of reference interval and evaluation of cutoff value of proGRP
Basic objectives2
Others
Basic objectives -Others
1) Equivalency confirmation of the basic performance
2) Setting of reference interval and evaluation of cutoff value
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Equivalency confirmation
2) Cutoff value
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
455
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Takahashi |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
t.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ono |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
Homepage URL
a.ono@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Roche Diagnostics K.K.
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
| 2014 | Year | 09 | Month | 26 | 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
| 2013 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 04 | Month | 09 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 29 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 26 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017745
