SarcoidosisNCT00837668
Stromal Gene Expression During Pulmonary Sarcoidosis
An observational study of Sarcoidosis, run by Ohio State University at 1 site in United States.
Trial summary
to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Feb 2012
- 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
Study population: patients from sarcoidosis clinic
Who may be able to join
- diagnosis of sarcoidosis
Who cannot join
- inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.
Read the detailed description
to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.
- Conditions
- Sarcoidosis
- Keywords
- sarcoidosis, stromal gene expression, pulmonary sarcoidosis, bronchoscopy
- Medical subject headings
- Sarcoidosis, Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sarcoidosis | sarcoidosis patients undergoing clinical bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis.
Measured: end of study
Secondary outcomes (1)
To Determine if Gene Expression Patterns Correlate With The Severity of Illness Of Sarcoidosis Patients
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startApr 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliott Crouser MD, Ohio State University
- Investigators
- Elliott Crouser, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837668
- Sponsor's protocol ID
- 2005H0018
- Status last verified
- Jun 2017
- First submitted
- 4 Feb 2009
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stromal Gene Expression During Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT00837668
- Acronym / sponsor ID
- 2005H0018
- Conditions
- Sarcoidosis
- Keywords
- sarcoidosis, stromal gene expression, pulmonary sarcoidosis, bronchoscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Feb 2009 (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.
to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.
Detailed description
to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sarcoidosis | – | –sarcoidosis patients undergoing clinical bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from sarcoidosis clinic
Key inclusion criteria (1 listed)
- diagnosis of sarcoidosis
Key exclusion criteria (1 listed)
- inability to provide consent
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
To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis.
Time frame: end of study
1 secondary outcome
To Determine if Gene Expression Patterns Correlate With The Severity of Illness Of Sarcoidosis Patients
Time frame: end of study
Results and safety
The study was stopped early (reason given: Interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
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Sarcoidosis
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.
Elliott Crouser, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Ohio State University at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: Interim analysis). 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.
What does the primary outcome measure?
To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis. (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2017.