Healthy VolunteerTRANSIMMUNOMNCT02466217
Phenomics in Autoimmune and Inflammatory Diseases
An observational study of Healthy Volunteer and Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- 1: AID groups
- How many people
- 537 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jul 2015to 18 Jul 2022
- 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: The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy
Who may be able to join
- Presenting either:
- one IAD from our list (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/Tumor Necrosis Factor (TNF)-receptor Associated Periodic Syndrome, Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes)
- or an unclassified IAD : a knee and/or hip arthritis or a muscular dystrophy
- or healthy subject
- Good veins
- Affiliation to a social security system
- Informed consent form, signed by the participant and the investigator, prior all needed examination
Who cannot join
- For IADs patients
- Unauthorized treatment (anticancer chemotherapy)
- For Healthy volunteers
- Contra-indications for donating blood except from age
- Known history of IAD (eg: Psoriasis)
- Common exclusion criteria:
Show all 12Show fewer
- Pregnant woman
- Still under the exclusion period from another biomedical study
- Psychiatric or addiction pathology who could interfere with the ability to fulfill the protocol needs or to provide an informed consent
- Patient under a legal protection
- Chronic lifelong viral infection unrelated to the pathology
- Mild infection within the last 3 months
Trial locations and contacts
2 sites in 1 country.
France2 sites
Rhumatologie - Hôpital Saint-Antoine
Paris, 75012
CIC Paris-Est, Hôpital PITIE SALPETRIERE
Paris, 75013
About this study
Official title: Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases
The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.
Read the detailed description
The family of inflammatory/autoimmune systemic diseases (IAD) represents a large group of human diseases. For most if not all of these IAD, the pathophysiological processes or exact causes remain poorly understood. Progresses in molecular understanding of these IAD have led to realize that these are not two distinct categories of diseases. Rather they form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa.
Using systems biology, the investigator aims to improve the understanding of these diseases, to identify novel genes/pathways involved, specific or across the diseases, and to discover biomarkers and potential therapeutic targets.
The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, Familial Mediterranean Fever (FMF), Cryopyrin-Associated Periodic Syndromes (CAPS) /Tumor Necrosis Factor-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy.
The biological investigations will notably comprise: immunomics (comprehensive evaluation of peripheral blood cell subsets and serum immunoproteomics, including autoantibodies); transcriptomics; Human Leukocyte Antigen (HLA)-phenotyping; genomics; T-Cell Receptor (TCR) sequencing and microbiota studies.
After signing the informed consent, the subject attends only one visit (Day 0) during which all biological samples will be taken and all clinical information collected.
- Conditions
- Healthy Volunteer, Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome
- Being tested
- 1: AID groups, 2: Control groups
- Keywords
- Auto-immune disease, Auto-inflammatory disease, Omics, System biology
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Antiphospholipid Syndrome, Vasculitis, Uveitis, Myositis, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1: AID groupsOther
Clinical and Biological investigations
2: Control groupsOther
Clinical and Biological investigations
| Study group | Role | What they receive |
|---|---|---|
| 1: AID groups | Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes Receives: Other: 1: AID groups | |
| 2: Control groups | knee arthritis, hip arthritis, muscular dystrophy, healthy subject Receives: Other: 2: Control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total peripheral blood gene expression between patients, expressed as fluorescence intensity
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Measured: at day 0, no follow-up
Tregs and Tconvs T cell receptor repertoire, expressed as the % of unique TCR sequences
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Measured: at day 0, no follow-up
HLA type and SNPs expressed as the occurrence events across patients
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Measured: at day 0, no follow-up
Microbiote species identification expressed as the % of species per family and genus
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Measured: at day 0, no follow-up
Cytokines and chemokines expressed as fluorescence intensity
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Measured: at day 0, no follow-up
Immune cells phenotyping expressed as the each cell type % within total PBMCs
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Measured: at day 0, no follow-up
Secondary outcomes (12)
Changes in gene expression intensity between patients and healthy controls - for each Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Changes in Tregs and Tconvs TCR sequence frequencies between patients and healthy controls - for each Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Characterization of HLA and SNP profiles in patients and healthy controls - for each Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Changes in Microbiote composition between patients and healthy controls - for each Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Changes in cytokines and chemokines expression levels between patients and healthy controls - for each Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Changes in immune cells frequencies between patients and healthy controls - for each Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Identification of specific and common gene expression levels between patients - between Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Identification of specific and common Tregs and Tconvs TCR sequence frequencies between patients - between Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Characterization of specific and common HLA and SNP profiles in patients - between Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Identification of specific and common microbiote composition between patients - between Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Identification of specific and common cytokines and chemokines expression levels between patients - between Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Characterization specific and common variations in immune cells frequencies between patients - between Disease cohorts
Identification of new biomarkers and potential therapeutic by multiscale analysis
Measured: at day 0, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start29 Jul 2015
- Primary completion14 Jul 2022
- Study completion18 Jul 2022
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 Healthy VolunteerStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- David KLATZMANN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466217
- Sponsor's protocol ID
- P141006
- Other IDs
- 2015-A00558-41
- Acronym
- TRANSIMMUNOM
- Status last verified
- Aug 2023
- First submitted
- 12 May 2015
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellul P, Tchitchek N, Kvedaraviciute G, Lorenzon R, Melki I, Delorme R, Rosenzwajg M, Klatzmann D. An immunometabolic signature of major depressive disorder in systemic lupus erythematosus. Ann Rheum Dis. 2026 Aug;85(8):1596-1609. doi: 10.1016/j.ard.2026.02.019. Epub 2026 Mar 20.
PubMed 41862407Tchitchek N, Binvignat M, Roux A, Pitoiset F, Dubois J, Marguerit G, Saadoun D, Cacoub P, Sellam J, Berenbaum F, Hartemann A, Amouyal C, Lorenzon R, Mariotti-Ferrandiz E, Rosenzwajg M, Klatzmann D. Deep immunophenotyping reveals that autoimmune and autoinflammatory disorders are spread along two immunological axes capturing disease inflammation levels and types. Ann Rheum Dis. 2024 Apr 11;83(5):638-650. doi: 10.1136/ard-2023-225179.
PubMed 38182406Lorenzon R, Mariotti-Ferrandiz E, Aheng C, Ribet C, Toumi F, Pitoiset F, Chaara W, Derian N, Johanet C, Drakos I, Harris S, Amselem S, Berenbaum F, Benveniste O, Bodaghi B, Cacoub P, Grateau G, Amouyal C, Hartemann A, Saadoun D, Sellam J, Seksik P, Sokol H, Salem JE, Vicaut E, Six A, Rosenzwajg M, Bernard C, Klatzmann D. Clinical and multi-omics cross-phenotyping of patients with autoimmune and autoinflammatory diseases: the observational TRANSIMMUNOM protocol. BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.
PubMed 30166293
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases
- ClinicalTrials.gov ID
- NCT02466217
- Acronym / sponsor ID
- TRANSIMMUNOM / P141006
- Conditions
- Healthy Volunteer, Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome
- Keywords
- Auto-immune disease, Auto-inflammatory disease, Omics, System biology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 9 Jun 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 family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.
Detailed description
The family of inflammatory/autoimmune systemic diseases (IAD) represents a large group of human diseases. For most if not all of these IAD, the pathophysiological processes or exact causes remain poorly understood. Progresses in molecular understanding of these IAD have led to realize that these are not two distinct categories of diseases. Rather they form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa.
Using systems biology, the investigator aims to improve the understanding of these diseases, to identify novel genes/pathways involved, specific or across the diseases, and to discover biomarkers and potential therapeutic targets.
The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, Familial Mediterranean Fever (FMF), Cryopyrin-Associated Periodic Syndromes (CAPS) /Tumor Necrosis Factor-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy.
The biological investigations will notably comprise: immunomics (comprehensive evaluation of peripheral blood cell subsets and serum immunoproteomics, including autoantibodies); transcriptomics; Human Leukocyte Antigen (HLA)-phenotyping; genomics; T-Cell Receptor (TCR) sequencing and microbiota studies.
After signing the informed consent, the subject attends only one visit (Day 0) during which all biological samples will be taken and all clinical information collected.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: AID groups | – | Other: 1: AID groupsRheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes |
| 2: Control groups | – | Other: 2: Control groupsknee arthritis, hip arthritis, muscular dystrophy, healthy subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy
Key inclusion criteria (7 listed)
- Presenting either:
- Good veins
- Affiliation to a social security system
- Informed consent form, signed by the participant and the investigator, prior all needed examination
Key exclusion criteria (12 listed)
- For IADs patients
- For Healthy volunteers
- Common exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1: AID groupsClinical and Biological investigations | Other | 1: AID groups |
| 2: Control groupsClinical and Biological investigations | Other | 2: Control groups |
Primary outcome
Total peripheral blood gene expression between patients, expressed as fluorescence intensity
Time frame: at day 0, no follow-up
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Tregs and Tconvs T cell receptor repertoire, expressed as the % of unique TCR sequences
Time frame: at day 0, no follow-up
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
HLA type and SNPs expressed as the occurrence events across patients
Time frame: at day 0, no follow-up
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Microbiote species identification expressed as the % of species per family and genus
Time frame: at day 0, no follow-up
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Cytokines and chemokines expressed as fluorescence intensity
Time frame: at day 0, no follow-up
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Immune cells phenotyping expressed as the each cell type % within total PBMCs
Time frame: at day 0, no follow-up
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
12 secondary outcomes
Changes in gene expression intensity between patients and healthy controls - for each Disease cohorts
Time frame: at day 0, no follow-up
Changes in Tregs and Tconvs TCR sequence frequencies between patients and healthy controls - for each Disease cohorts
Time frame: at day 0, no follow-up
Characterization of HLA and SNP profiles in patients and healthy controls - for each Disease cohorts
Time frame: at day 0, no follow-up
Changes in Microbiote composition between patients and healthy controls - for each Disease cohorts
Time frame: at day 0, no follow-up
Changes in cytokines and chemokines expression levels between patients and healthy controls - for each Disease cohorts
Time frame: at day 0, no follow-up
Changes in immune cells frequencies between patients and healthy controls - for each Disease cohorts
Time frame: at day 0, no follow-up
Identification of specific and common gene expression levels between patients - between Disease cohorts
Time frame: at day 0, no follow-up
Identification of specific and common Tregs and Tconvs TCR sequence frequencies between patients - between Disease cohorts
Time frame: at day 0, no follow-up
Characterization of specific and common HLA and SNP profiles in patients - between Disease cohorts
Time frame: at day 0, no follow-up
Identification of specific and common microbiote composition between patients - between Disease cohorts
Time frame: at day 0, no follow-up
Identification of specific and common cytokines and chemokines expression levels between patients - between Disease cohorts
Time frame: at day 0, no follow-up
Characterization specific and common variations in immune cells frequencies between patients - between Disease cohorts
Time frame: at day 0, no follow-up
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 8 Aug 2023.
- Derived from this study: PubMed 41862407Ellul P, Tchitchek N, Kvedaraviciute G, Lorenzon R, Melki I, Delorme R, Rosenzwajg M, Klatzmann D. An immunometabolic signature of major depressive disorder in systemic lupus erythematosus. Ann Rheum Dis. 2026 Aug;85(8):1596-1609. doi: 10.1016/j.ard.2026.02.019. Epub 2026 Mar 20.
- Derived from this study: PubMed 38182406Tchitchek N, Binvignat M, Roux A, Pitoiset F, Dubois J, Marguerit G, Saadoun D, Cacoub P, Sellam J, Berenbaum F, Hartemann A, Amouyal C, Lorenzon R, Mariotti-Ferrandiz E, Rosenzwajg M, Klatzmann D. Deep immunophenotyping reveals that autoimmune and autoinflammatory disorders are spread along two immunological axes capturing disease inflammation levels and types. Ann Rheum Dis. 2024 Apr 11;83(5):638-650. doi: 10.1136/ard-2023-225179.
- Derived from this study: PubMed 30166293Lorenzon R, Mariotti-Ferrandiz E, Aheng C, Ribet C, Toumi F, Pitoiset F, Chaara W, Derian N, Johanet C, Drakos I, Harris S, Amselem S, Berenbaum F, Benveniste O, Bodaghi B, Cacoub P, Grateau G, Amouyal C, Hartemann A, Saadoun D, Sellam J, Seksik P, Sokol H, Salem JE, Vicaut E, Six A, Rosenzwajg M, Bernard C, Klatzmann D. Clinical and multi-omics cross-phenotyping of patients with autoimmune and autoinflammatory diseases: the observational TRANSIMMUNOM protocol. BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.
Related trials for Healthy Volunteer
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
David KLATZMANN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 7 inclusion and 12 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Total peripheral blood gene expression between patients, expressed as fluorescence intensity (time frame: at day 0, no follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02466217, 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 8 Aug 2023.