Ankylosing SpondylitisGENOSPANCT02525042
Genetic Susceptibility to Ankylosing Spondylitis (AS) by Functional Genomics Approach
An observational study of Ankylosing Spondylitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to identify in the candidate regions of differentially expressed genes by comparing the transcriptome of dendritic cells derived from circulating monocytes between cases and controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Jan 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Ankylosing Spondylitis (AS) and matched family controls from families having a LOD score ≥ 0.15.
Who may be able to join
- Patient >18 and
- Axial SpA patients fulfilling the ASAS criteria (31) and belonging to families already included in genetic analyses previously made by our Consortium.
- Family controls without AS and matched to AS cases on age, sex and HLA-B27 positivity.
- Non-family independent healthy controls
- Written informed consent
Who cannot join
- Person specially Protected
- Persons living abroad, in the DOM-TOM
Trial locations and contacts
1 site in 1 country.
France1 site
Ambroise Paré Hospital
Boulogne-Billancourt, Hauts-De-Seine, 92100
About this study
Official title: Study of the Genetic Susceptibility to Ankylosing Spondylitis by Functional Genomics Approach
The main objective is to identify in the candidate regions of differentially expressed genes by comparing the transcriptome of dendritic cells derived from circulating monocytes between cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and depending on haplotype association studies to correlate the differences of gene expression and genetic variations with susceptibility to AS.
Read the detailed description
This is a matched case-control study to identify genetic susceptibility factors to Ankylosing Spondylitis (AS).
Patients and family controls selected from 154 families have been included in genome-wide linkage screening, comprising 440 patients and 904 individuals genotyped using microarrays Affymetrix® 250,000 single-nucleotide polymorphism (SNPs). For each locus,families with a LOD score of 0;15 in predefined region were retained. In these families will be selected a patient and a healthy control of the same sex, if possible, siblings and of comparable age (<10 years apart).
The patients and controls will be contacted by mail and / or telephone to obtain their participation in this study. An updating Questionnaire of AS events will be sent to them, particularly to check that the family controls did not develop AS since their inclusion in the genetic study.
Patient and family controls recruitment and obtaining their dendritic cells (DC) will be made during the first year.
After signing the informed consent, 60ml of whole blood will be taken from each included subject. The cells obtained from blood samples (leukocytes) will be cultured in the laboratory for seven days and used to extract the RNA that will be used to conduct the research. Some of these cells as well as their RNA will be frozen and can be thawed for later use if required.
Mononuclear cells are isolated from whole blood by gradient centrifugation (Ficoll). CD14 + monocytes will be selected after labeling with an anti-CD14 antibody coupled to ferromagnetic beads (Dynabeads) and the magnet system Dynal, then differentiated in the presence of GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) and IL-4 (Interleukine 4) for 6 days into immature DC (dendritic cells), according to a protocol validated in the laboratory and used in routine. DC maturation is then induced by the addition of lipopolysaccharide E. coli (Sigma) for 18 hours. The pellets of DC will be retained in RNAlater® for extracting RNA.
A transcriptomic study of mature DCs will be carried at the end of the recruitment and will run for two months, including one month of experimentation and 1 month for analysis. This study will be performed using microarrays of genome-wide exon-centric expression. The analyzes will be performed separately for each locus of interest and will bear on the expression of genes localized in each region. The level of transcripts will be normalized for patients and family controls compared to that of a group of 15 controls from the general population already obtained. For each locus, genes having statistically different expression between the group of patients and the family controls and a differential expression ≥ 1 will be identified. The expression level of these genes will then be verified by quantitative real-time PCR (polymerase chain reaction).
The positional and functional candidate genes identified due to a differential expression of their transcripts will be fully re-sequenced to search for polymorphisms that may be responsible for a change in their level of expression.
The investigators expect to study one to three genes per region. The re-sequencing will be performed primarily in patients and family controls with a different level of expression of these genes. Polymorphisms distributed differently between these two populations will be retained for the rest of the study.
The re-sequencing of these candidate genes will be spread over a period of 4 months.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Dendritic cells (DC), RNA, Axial spondyloarthritis, Lod score, Human leucocyte antigen (HLA-B27)
- Medical subject headings
- Spondylitis, Ankylosing, Axial Spondyloarthritis
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 |
|---|---|---|
| Patients with ankylosing spondylitis | Patients with ankylosing spondylitis | |
| Comparator 1 | family controls | |
| Comparator 2 | population controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the transcriptome of dendritic cells derived from circulating monocytes between cases and controls
Measured: 18 months
Secondary outcomes (1)
Assessment of manifestations of Ankylosing Spondylitis (AS) according an Updating Questionnaire.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startAug 2011
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime BREBAN, MD, PhD, Principal investigator, Ambroise Paré Hospital, 92100 Boulogne-Billancourt, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525042
- Sponsor's protocol ID
- NI09031
- Acronym
- GENOSPA
- Status last verified
- Jun 2015
- First submitted
- 3 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Genetic Susceptibility to Ankylosing Spondylitis by Functional Genomics Approach
- ClinicalTrials.gov ID
- NCT02525042
- Acronym / sponsor ID
- GENOSPA / NI09031
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Dendritic cells (DC), RNA, Axial spondyloarthritis, Lod score, Human leucocyte antigen (HLA-B27)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2014 (actual)
- First posted
- 17 Aug 2015 (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 main objective is to identify in the candidate regions of differentially expressed genes by comparing the transcriptome of dendritic cells derived from circulating monocytes between cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and depending on haplotype association studies to correlate the differences of gene expression and genetic variations with susceptibility to AS.
Detailed description
This is a matched case-control study to identify genetic susceptibility factors to Ankylosing Spondylitis (AS).
Patients and family controls selected from 154 families have been included in genome-wide linkage screening, comprising 440 patients and 904 individuals genotyped using microarrays Affymetrix® 250,000 single-nucleotide polymorphism (SNPs). For each locus,families with a LOD score of 0;15 in predefined region were retained. In these families will be selected a patient and a healthy control of the same sex, if possible, siblings and of comparable age (<10 years apart).
The patients and controls will be contacted by mail and / or telephone to obtain their participation in this study. An updating Questionnaire of AS events will be sent to them, particularly to check that the family controls did not develop AS since their inclusion in the genetic study.
Patient and family controls recruitment and obtaining their dendritic cells (DC) will be made during the first year.
After signing the informed consent, 60ml of whole blood will be taken from each included subject. The cells obtained from blood samples (leukocytes) will be cultured in the laboratory for seven days and used to extract the RNA that will be used to conduct the research. Some of these cells as well as their RNA will be frozen and can be thawed for later use if required.
Mononuclear cells are isolated from whole blood by gradient centrifugation (Ficoll). CD14 + monocytes will be selected after labeling with an anti-CD14 antibody coupled to ferromagnetic beads (Dynabeads) and the magnet system Dynal, then differentiated in the presence of GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) and IL-4 (Interleukine 4) for 6 days into immature DC (dendritic cells), according to a protocol validated in the laboratory and used in routine. DC maturation is then induced by the addition of lipopolysaccharide E. coli (Sigma) for 18 hours. The pellets of DC will be retained in RNAlater® for extracting RNA.
A transcriptomic study of mature DCs will be carried at the end of the recruitment and will run for two months, including one month of experimentation and 1 month for analysis. This study will be performed using microarrays of genome-wide exon-centric expression. The analyzes will be performed separately for each locus of interest and will bear on the expression of genes localized in each region. The level of transcripts will be normalized for patients and family controls compared to that of a group of 15 controls from the general population already obtained. For each locus, genes having statistically different expression between the group of patients and the family controls and a differential expression ≥ 1 will be identified. The expression level of these genes will then be verified by quantitative real-time PCR (polymerase chain reaction).
The positional and functional candidate genes identified due to a differential expression of their transcripts will be fully re-sequenced to search for polymorphisms that may be responsible for a change in their level of expression.
The investigators expect to study one to three genes per region. The re-sequencing will be performed primarily in patients and family controls with a different level of expression of these genes. Polymorphisms distributed differently between these two populations will be retained for the rest of the study.
The re-sequencing of these candidate genes will be spread over a period of 4 months.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with ankylosing spondylitis | – | –Patients with ankylosing spondylitis |
| Comparator 1 | – | –family controls |
| Comparator 2 | – | –population controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Ankylosing Spondylitis (AS) and matched family controls from families having a LOD score ≥ 0.15.
Key inclusion criteria (5 listed)
- Patient >18 and
- Axial SpA patients fulfilling the ASAS criteria (31) and belonging to families already included in genetic analyses previously made by our Consortium.
- Family controls without AS and matched to AS cases on age, sex and HLA-B27 positivity.
- Non-family independent healthy controls
- Written informed consent
Key exclusion criteria (2 listed)
- Person specially Protected
- Persons living abroad, in the DOM-TOM
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
Comparison of the transcriptome of dendritic cells derived from circulating monocytes between cases and controls
Time frame: 18 months
1 secondary outcome
Assessment of manifestations of Ankylosing Spondylitis (AS) according an Updating Questionnaire.
Time frame: 1 day
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 17 Aug 2015.
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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.
Maxime BREBAN, MD, PhD principal investigator
Ambroise Paré Hospital, 92100 Boulogne-Billancourt, France
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 Ankylosing Spondylitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 17 Aug 2015. 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 France. 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 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.
What does the primary outcome measure?
Comparison of the transcriptome of dendritic cells derived from circulating monocytes between cases and controls (time frame: 18 months). 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 17 Aug 2015.