UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019472
Receipt number R000022518
Scientific Title Shotgun Proteomics and Biomaker Discovery in Pulmonary Diseases
Date of disclosure of the study information 2015/10/23
Last modified on 2019/04/26 09:07:59

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Basic information

Public title

Shotgun Proteomics and Biomaker Discovery in Pulmonary Diseases

Acronym

Proteomics in Pulmonary Diseases

Scientific Title

Shotgun Proteomics and Biomaker Discovery in Pulmonary Diseases

Scientific Title:Acronym

Proteomics in Pulmonary Diseases

Region

Japan


Condition

Condition

pulmonary diseases

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Shotogun proteomic and biomarker discovery

Basic objectives2

Others

Basic objectives -Others

Identification of biomarkers for pulmonary diseases

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Association with disease severity and prognisis

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

Patients with pulmonary diseases

Key exclusion criteria

Not applicapable

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Takafumi
Middle name
Last name Suda

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

431-3192

Address

1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka 431-3129 Japan

TEL

+81-53-435-2263

Email

yuzosuzu@hama-med.ac.jp


Public contact

Name of contact person

1st name Yuzo
Middle name
Last name Suzuki

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

431-3192

Address

1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka 431-3129 Japan

TEL

+81-53-435-2263

Homepage URL


Email

yuzosuzu@hama-med.ac.jp


Sponsor or person

Institute

Second Division, Department of Internal Medicine,Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Second Division, Department of Internal Medicine,Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Hospital Organization, Tenryu Hospital
Serrei Mikatahara Hospital
Shizuoka General Hospital
Iwata City Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan

Tel

053-435-2263

Email

yuzosuzu@hama-med.ac.jp


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

2015 Year 10 Month 23 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

Enrolling by invitation

Date of protocol fixation

2015 Year 10 Month 23 Day

Date of IRB

2015 Year 10 Month 05 Day

Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: multicenter case control study
Objective:Patients with pulmonary diseases, admittedd at our institute between Oct 2015 to Sep 2018.
Measurements:Blood, Sputum, clinical data


Management information

Registered date

2015 Year 10 Month 23 Day

Last modified on

2019 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022518


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name