Development of the Danish Prospective Sarcoidosis Registr... | NCT04388566

Studies
Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort

NCT04388566

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 6, 2022Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Sarcoidosis

Interventions

Not provided

Countries

Denmark

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Jan 30, 2022Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

May 11, 2020

First Submission Date that Met QC Criteria

May 11, 2020

First Posted Date

May 14, 2020Actual

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

Jun 3, 2022

Last Update Posted Date

Jun 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Development of a Danish Sarcoidosis Registry. Characterization of a cohort of sarcoidosis patients with respect to the baseline epidemiological characteristics, comorbidities, radiology, histopathology, diagnostic investigations and treatment.

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

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterization of Danish sarcoid patients	Epidemiology and Baseline characteristics of a Danish Sarcoidosis Cohort	2 years
Feasibility and completion of a Sarcoidosis Registry.	Development of a Danish sarcoidosis registry Data on epidemiology, clinical characteristics, diagnosis and management will be registered	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of sarcoidosis
Signed informed consent

Exclusion Criteria:

Inability or unwillingness to adhere to the study
Inability to give informed consent

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

Patients with sarcoidosis seen in the Department of Respiratory Diseases, Aarhus Denmark

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus N		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D012507	Sarcoidosis

Ancestor Terms

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

Browse Leaves

Not provided

Browse Branches

Not provided