UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020542
Receipt number R000023717
Scientific Title Fibrosis in Childhood Interstitial Lung Diseases: Correlation with Clinical Characteristics
Date of disclosure of the study information 2016/01/15
Last modified on 2017/02/16 14:44:43

* 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

Fibrosis in Childhood Interstitial Lung Diseases: Correlation with Clinical
Characteristics

Acronym

Fibrosis in Childhood Interstitial Lung Diseases

Scientific Title

Fibrosis in Childhood Interstitial Lung Diseases: Correlation with Clinical
Characteristics

Scientific Title:Acronym

Fibrosis in Childhood Interstitial Lung Diseases

Region

Africa


Condition

Condition

Childhood Interstitial Lung Diseases

Classification by specialty

Pneumology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate fibrosis and lung elastin destruction in pediatric patients with interstitial lung disease (chILD) during acute exacerbation and to correlate findings with demographic, clinical characteristics and outcome.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Markers of fibrosis (TGF-beta1, sFas, CCN2) and elastin destruction (UDes/UCr) were increased in chILD. So blockage of their pathways signals may offer novel therapeutic targets.

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

Other

Interventions/Control_1

markers of fibrosis

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

2 years-old <=

Age-upper limit

5 years-old >=

Gender

Male and Female

Key inclusion criteria

chILD diagnostic criteria were at least three of following criteria: (1)

respiratory symptoms (e.g., cough, rapid and/or difficult breathing, or exercise

intolerance); (2) respiratory signs (e.g., resting tachypnea, adventitious sounds,

retractions, digital clubbing, failure to thrive, or respiratory failure); (3) hypoxemia;

(4) diffuse abnormalities on chest X-ray (CXR) or high resultion computed

tomography (HRCT).

Key exclusion criteria

Patients were excluded from this study if they

hadbronchopulmonary dysplasia, congenital heart disease, primary or acquired

immunodeficiency, primary autoimmune disorder, cystic fibrosis or pulmonary

tuberculosis.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Khaled Saad

Organization

Assiut university

Division name

faculty of medicine

Zip code


Address

Faculty of Medicine, Assiut University, Assiut, Egypt

TEL

+20882413683

Email

med@aun.edu.eg


Public contact

Name of contact person

1st name
Middle name
Last name Khaled Saad

Organization

Faculty of medicine, University of Assiut, Assiut 71516, Egypt.

Division name

Faculty of medicine

Zip code


Address

Faculty of medicine, University of Assiut, Assiut 71516, Egypt.

TEL

+20882368373

Homepage URL


Email

med@aun.edu.eg


Sponsor or person

Institute

Grant office, Faculty of Medicine, Assiut University, Assiut, Egypt

Institute

Department

Personal name



Funding Source

Organization

Grant office, Faculty of Medicine, Assiut University, Assiut, Egypt, grant number (1317), grant office number +20882413683

Organization

Division

Category of Funding Organization

Other

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

2016 Year 01 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Markers of fibrosis (TGF-beta1, sFas, CCN2) and elastin destruction (UDes/UCr) were increased in chILD. blockage of their pathways signals may offer novel therapeutic targets.

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

Main results already published

Date of protocol fixation

2012 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2015 Year 06 Month 01 Day

Date of closure to data entry

2015 Year 07 Month 01 Day

Date trial data considered complete

2015 Year 08 Month 01 Day

Date analysis concluded

2015 Year 10 Month 01 Day


Other

Other related information

blockage of their pathways signals may offer novel therapeutic targets.


Management information

Registered date

2016 Year 01 Month 13 Day

Last modified on

2017 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023717


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name