Interstitial Lung DiseasesNCT00267800
Database of Interstitial Lung Diseases
An observational study of Interstitial Lung Diseases, run by St. Antonius Hospital at 4 sites in Netherlands.
Trial summary
The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for example to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the cause of ILDs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases
- How many people
- 100,000 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jan 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of an ILD, as stated by the American Thoracic Society (ATS)
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
St. Antonius Hospital
Nieuwegein, 3435CM
Diakonessenhuis
Utrecht, 3508 TG
Mesos Medisch Centrum
Utrecht, 3527 CE
UMC Utrecht
Utrecht, 3584 CX
About this study
Official title: Registration of Clinical Data and DNA/Serum of Patients With Interstitial Lung Diseases (ILD)
The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for example to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the cause of ILDs.
Read the detailed description
Protocol title: 'Registration of clinical data and DNA of patients with Interstitial Lung Disease (ILD)' Rationale: The etiopathogenesis of most Interstitial Lung Diseases (ILDs) is still unknown. Further research, e.g. to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the etiopathogenesis of ILDs.
Objective: Availability of relevant clinical data and DNA/serum samples of ILD patients in a database. Those data can be used for future research.
Study design: A prospective observational study
Study population: Patients diagnosed with ILD attending the pulmonology department in participating hospitals.
Intervention: a blood sample is taken from each patient. Furthermore, additional information is collected from the medical file.
Main study parameters/endpoints: DNA and serum sample, demographic variables, medical information, occupational history and hobbies.
Nature and extent of the burden and risks associated with participation, group relatedness: two tubes of blood will be drawn from the patients. The risks of drawing blood from a vein are minimal.
- Conditions
- Interstitial Lung Diseases
- Keywords
- Lung disease, Interstitial, Sarcoidosis, Pulmonary fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Sarcoidosis, Pulmonary Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100,000 participants
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Investigators
- J.M.M. van den Bosch, M.D., Principal investigator, St. Antonius HospitalJ.C. Grutters, M.D., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267800
- Sponsor's protocol ID
- R05.08/A
- Status last verified
- Dec 2005
- First submitted
- 19 Dec 2005
- Last updated
- 8 Aug 2008
- Results posted
- No
Publications
Drent M, Wijnen PA, Jessurun NT, Harmsze AM, Bekers O, Bast A. Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease. Drug Saf. 2024 Apr;47(4):355-363. doi: 10.1007/s40264-024-01400-0. Epub 2024 Mar 9.
PubMed 38460070Jessurun NT, Drent M, Wijnen PA, Harmsze AM, van Puijenbroek EP, Bekers O, Bast A. Role of Drug-Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity. Drug Saf. 2021 Nov;44(11):1179-1191. doi: 10.1007/s40264-021-01105-8. Epub 2021 Oct 4.
PubMed 34606062
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration of Clinical Data and DNA/Serum of Patients With Interstitial Lung Diseases (ILD)
- ClinicalTrials.gov ID
- NCT00267800
- Acronym / sponsor ID
- R05.08/A
- Conditions
- Interstitial Lung Diseases
- Keywords
- Lung disease, Interstitial, Sarcoidosis, Pulmonary fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 21 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for example to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the cause of ILDs.
Detailed description
Protocol title: 'Registration of clinical data and DNA of patients with Interstitial Lung Disease (ILD)' Rationale: The etiopathogenesis of most Interstitial Lung Diseases (ILDs) is still unknown. Further research, e.g. to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the etiopathogenesis of ILDs.
Objective: Availability of relevant clinical data and DNA/serum samples of ILD patients in a database. Those data can be used for future research.
Study design: A prospective observational study
Study population: Patients diagnosed with ILD attending the pulmonology department in participating hospitals.
Intervention: a blood sample is taken from each patient. Furthermore, additional information is collected from the medical file.
Main study parameters/endpoints: DNA and serum sample, demographic variables, medical information, occupational history and hobbies.
Nature and extent of the burden and risks associated with participation, group relatedness: two tubes of blood will be drawn from the patients. The risks of drawing blood from a vein are minimal.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of an ILD, as stated by the American Thoracic Society (ATS)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Derived from this study: PubMed 38460070Drent M, Wijnen PA, Jessurun NT, Harmsze AM, Bekers O, Bast A. Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease. Drug Saf. 2024 Apr;47(4):355-363. doi: 10.1007/s40264-024-01400-0. Epub 2024 Mar 9.
- Derived from this study: PubMed 34606062Jessurun NT, Drent M, Wijnen PA, Harmsze AM, van Puijenbroek EP, Bekers O, Bast A. Role of Drug-Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity. Drug Saf. 2021 Nov;44(11):1179-1191. doi: 10.1007/s40264-021-01105-8. Epub 2021 Oct 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.M.M. van den Bosch, M.D. principal investigator
St. Antonius Hospital
J.C. Grutters, M.D. principal investigator
St. Antonius Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Diseases, run by St. Antonius Hospital at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267800, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.