Research with human participants

Overview of medical research in the Netherlands

Systemic sclerosis: CT-derived evaluation of interstitial lung disease and pulmonary vasculopathy for assessment of progression of disease.
Research protocol for extended volume HRCT-thorax in patients with systemic sclerosis participating in a 2 *day multidisciplinary team care program of the department of Rheumatology and Pulmonology

Published:
Last updated:

zie nederlandse samenvatting

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Autoimmune disorders
Study type
Observational non invasive

ID

NL-OMON44504

Source

ToetsingOnline

Brief title

HRCT thorax in patients with systemic sclerosis and fibrotic lung diseases

Condition

  • Autoimmune disorders
  • Connective tissue disorders (excl congenital)
  • Lower respiratory tract disorders (excl obstruction and infection)

Synonym

long fibrosis

Research involving

Human

Sponsors and support

Primary sponsor :
Leids Universitair Medisch Centrum
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
health care program, HRCT thorax, systemic sclerosis

Outcome measures

Primary outcome

zie nederlandse samenvatting

Secondary outcome

zie nederlandse samenvatting

Background summary

zie nederlandse samenvatting

Study objective

zie nederlandse samenvatting

Study design

zie nederlandse samenvatting

Study burden and risks

zie nederlandse samenvatting

Public
Leids Universitair Medisch Centrum

Albinusdreef 2
Leiden 2333 ZA
NL
Scientific
Leids Universitair Medisch Centrum

Albinusdreef 2
Leiden 2333 ZA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

1. Diagnosis of systemic sclerosis according to ACR/EULAR 2013 criteria or suspected / confirmed fibrotic lung disease
2. Age * 18 years
3. First consultation at Zorgpad Sclerodermie LUMC or the dedicated ILD outpatient clinic and high risk profile* and/or low DLCO/ and/or low FVC which indicates a standard HRCT scan
4. Life expectancy > 6 months
5. Able and willing to undergo annual follow-up for 3 consecutive years
6. Written informed consent

Exclusion criteria

1. Inability to perform pulmonary function testing

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Health services research

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
80
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL49323.058.14