UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000028192
Receipt number	R000032199
Scientific Title	Development of integrated database with clinical, radiological and pathological data of idiopatihc interstitial pneumonias (IIPs) for multidisciplinary discussions
Date of disclosure of the study information	2017/07/15
Last modified on	2022/02/07 13:38:35

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Basic information

Public title

Development of integrated database with clinical, radiological and pathological data of idiopatihc interstitial pneumonias (IIPs) for multidisciplinary discussions

Acronym

Development of integrated database with clinical, radiological and pathological data of IIPs

Scientific Title

Development of integrated database with clinical, radiological and pathological data of idiopatihc interstitial pneumonias (IIPs) for multidisciplinary discussions

Scientific Title:Acronym

Development of integrated database with clinical, radiological and pathological data of IIPs

Region

Japan

Condition

idiopatihc interstitial pneumonias

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To develop database system integrating clinical, radiological and pathological data of IIPs and investigate clinical manifestation of IIPs

Basic objectives2

Others

Basic objectives -Others

To perform multidisciplinary discussions and investigate clinical manifestation of IIPs

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

To develop database system integrating clinical, radiological and pathological data of IIPs

Key secondary outcomes

To perform multidisciplinary discussions (MDD) and investigate clinical manifestation of IIPs based on MDD diagnosis.

Base

Study type

Others,meta-analysis etc

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients diagnosed as having idiopatihc interstitial pneumonias who underwent chest high-resolution computed tomography (HRCT) and surgical lung biopsy

Key exclusion criteria

The patients who diagnosed as having other pulmonary disease

Target sample size

500

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, 431-3192 Japan

TEL

053-435-2263

Email

suda@hama-med.ac.jp

Public contact

Name of contact person

1st name Tomoyuki

Middle name

Last name Fujisawa

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, 431-3192 Japan

TEL

053-435-2263

Homepage URL

Email

fujisawa@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

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan

Tel

053-435-2972

Email

rinri@hama-med.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 15 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

2017 Year 02 Month 10 Day

Date of IRB

2017 Year 05 Month 31 Day

Anticipated trial start date

2017 Year 07 Month 12 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

The subjects were patients diagnosed as having IIPs with surgical lung biopsy. Clinical data, HRCT images and lung histological specimens were collected retrospectively, and develop integrated database including clinical, radiological and pathological data.
Multidisciplinary discussions (MDD) were performed by a clinician, radiologist, and pathologist to get final diagnoses using the database.
Clinical manifestation were analyzed in each disease based on MDD diagnosis.

Management information

Registered date

2017 Year 07 Month 11 Day

Last modified on

2022 Year 02 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032199

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name