UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002807
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Pharma Valley Center, the Shizuoka Organization of Creation Industries
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.