The Role of Rheumatological Evaluation in the Management... | NCT01809574

Studies
The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease

NCT01809574

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Apr 9, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Connective Tissue Disease

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Mar 10, 2013

First Submission Date that Met QC Criteria

Mar 11, 2013

First Posted Date

Mar 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2015

Last Update Posted Date

Apr 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients with collagen related pulmonary fibrosis that are diagnosed by Rheumatologists compared to Pulmonologists.		two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 18 years old
ILD according to ATS/ERS guidelines
Signed inform consent

Exclusion Criteria:

Previous lung surgery
Other significant systemic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

60 patients that will refer to the pulmonary outpatient or inpatients department for evaluation due to ILD will be included

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Shitrit, Dr.	Contact	097471556		davids3@clalit.org.il

Overall Officials

Name	Affiliation	Role
David Shitrit, Dr	Head of Pulmonary departmant, Meir Medical Center.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center	Recruiting	Kfar Saba	Israel	972	Israel

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D054990	Idiopathic Pulmonary Fibrosis
D003240	Connective Tissue Diseases

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D011658	Pulmonary Fibrosis
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided