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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020542
Receipt No. 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

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

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
URL(English) https://upload.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


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