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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name