Lung DiseasesNCT00005542
Sarcoid Genetic Analysis (SAGA)
An observational study of Lung Diseases and Sarcoidosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify sarcoidosis susceptibility genes and to determine how these genes and environmental risk factors interact to cause sarcoidosis. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Sarcoidosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1999to Apr 2005
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify sarcoidosis susceptibility genes and to determine how these genes and environmental risk factors interact to cause sarcoidosis.
Read the detailed description
BACKGROUND:
Sarcoidosis is a rare systemic granulomatous disease that mainly affects young to middle aged adults, and more severely affects African Americans than Caucasians. The etiology of sarcoidosis is not yet known, and epidemiological studies have only identified general risk factors including age, sex, race, and family history. Sarcoidosis may also be influenced by environmental factors, although the particular environmental agents have not yet been clearly defined. While previous studies have provided evidence for familial clustering, little is known about the genes that influence predisposition to sarcoidosis.
DESIGN NARRATIVE:
This is a multicenter consortium genetic epidemiology study. The investigators will accomplish their goal by organizing a 10-site multi-center consortium to recruit an adequate sample of sarcoidosis families for analysis. They plan to use the affected sibling pair linkage analysis to scan the genome for linked chromosomal regions, transmission disequilibrium testing to evaluate candidate genes in those regions with evidence for linkage, and an environmental questionnaire to collect data to test for possible interactions of susceptibility genes with exogenous risk factors. Genotyping and analysis of data are scheduled to begin in July, 2001 with completion of all analysis by April, 2004.
The study consists of a Clinical Core, a Data Coordinating Core, and a Genetics Core with a DNA Processing Center and a Genotyping Center. Eight of the ten clinical centers comprising the Clinical Core are members of the ACCESS, A Case Control Etiology of Sarcoidosis Study.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Lung Diseases, Sarcoidosis
- Medical subject headings
- Lung Diseases, Sarcoidosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startMay 1999
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Iannuzzi, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005542
- Sponsor's protocol ID
- 5084
- Other IDs
- U01HL060263
- Status last verified
- Oct 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Maliarik MJ, Chen KM, Sheffer RG, Rybicki BA, Major ML, Popovich J Jr, Iannuzzi MC. The natural resistance-associated macrophage protein gene in African Americans with sarcoidosis. Am J Respir Cell Mol Biol. 2000 Jun;22(6):672-5. doi: 10.1165/ajrcmb.22.6.3745.
PubMed 10837363Rybicki BA, Walewski JL, Maliarik MJ, Kian H, Iannuzzi MC; ACCESS Research Group. The BTNL2 gene and sarcoidosis susceptibility in African Americans and Whites. Am J Hum Genet. 2005 Sep;77(3):491-9. doi: 10.1086/444435. Epub 2005 Jul 20.
PubMed 16080124Rybicki BA, Hirst K, Iyengar SK, Barnard JG, Judson MA, Rose CS, Donohue JF, Kavuru MS, Rabin DL, Rossman MD, Baughman RP, Elston RC, Maliarik MJ, Moller DR, Newman LS, Teirstein AS, Iannuzzi MC. A sarcoidosis genetic linkage consortium: the sarcoidosis genetic analysis (SAGA) study. Sarcoidosis Vasc Diffuse Lung Dis. 2005 Jun;22(2):115-22.
PubMed 16053026
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcoid Genetic Analysis (SAGA)
- ClinicalTrials.gov ID
- NCT00005542
- Acronym / sponsor ID
- 5084
- Conditions
- Lung Diseases, Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1999
- Study completion
- Apr 2005 (actual)
- First posted
- 26 May 2000 (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 identify sarcoidosis susceptibility genes and to determine how these genes and environmental risk factors interact to cause sarcoidosis.
Detailed description
BACKGROUND:
Sarcoidosis is a rare systemic granulomatous disease that mainly affects young to middle aged adults, and more severely affects African Americans than Caucasians. The etiology of sarcoidosis is not yet known, and epidemiological studies have only identified general risk factors including age, sex, race, and family history. Sarcoidosis may also be influenced by environmental factors, although the particular environmental agents have not yet been clearly defined. While previous studies have provided evidence for familial clustering, little is known about the genes that influence predisposition to sarcoidosis.
DESIGN NARRATIVE:
This is a multicenter consortium genetic epidemiology study. The investigators will accomplish their goal by organizing a 10-site multi-center consortium to recruit an adequate sample of sarcoidosis families for analysis. They plan to use the affected sibling pair linkage analysis to scan the genome for linked chromosomal regions, transmission disequilibrium testing to evaluate candidate genes in those regions with evidence for linkage, and an environmental questionnaire to collect data to test for possible interactions of susceptibility genes with exogenous risk factors. Genotyping and analysis of data are scheduled to begin in July, 2001 with completion of all analysis by April, 2004.
The study consists of a Clinical Core, a Data Coordinating Core, and a Genetics Core with a DNA Processing Center and a Genotyping Center. Eight of the ten clinical centers comprising the Clinical Core are members of the ACCESS, A Case Control Etiology of Sarcoidosis Study.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 10837363Maliarik MJ, Chen KM, Sheffer RG, Rybicki BA, Major ML, Popovich J Jr, Iannuzzi MC. The natural resistance-associated macrophage protein gene in African Americans with sarcoidosis. Am J Respir Cell Mol Biol. 2000 Jun;22(6):672-5. doi: 10.1165/ajrcmb.22.6.3745.
- Background: PubMed 16080124Rybicki BA, Walewski JL, Maliarik MJ, Kian H, Iannuzzi MC; ACCESS Research Group. The BTNL2 gene and sarcoidosis susceptibility in African Americans and Whites. Am J Hum Genet. 2005 Sep;77(3):491-9. doi: 10.1086/444435. Epub 2005 Jul 20.
- Background: PubMed 16053026Rybicki BA, Hirst K, Iyengar SK, Barnard JG, Judson MA, Rose CS, Donohue JF, Kavuru MS, Rabin DL, Rossman MD, Baughman RP, Elston RC, Maliarik MJ, Moller DR, Newman LS, Teirstein AS, Iannuzzi MC. A sarcoidosis genetic linkage consortium: the sarcoidosis genetic analysis (SAGA) study. Sarcoidosis Vasc Diffuse Lung Dis. 2005 Jun;22(2):115-22.
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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.
Michael Iannuzzi
Henry Ford Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Sarcoidosis, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00005542, which also lists 3 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 18 Feb 2016.