Disease Immunoglobulin G4TIFOLH4NCT02872441
Characterization of Tissular T Follicular Helper Cells in IgG4-RD
A study testing blood sample in people with Disease Immunoglobulin G4, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells predominance, and fibrosis in involved tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease Immunoglobulin G4
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2018to 8 Feb 2021
- Phase
- Interventional
- 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
- Patient with a diagnosis of disease associated with IgG4
- Patient signed a consent
- Patient affiliated to the social security scheme
Who cannot join
- Patients with a corticosteroid therapy current or less than 3 months.
- Patients with an immunosuppressive treatment or being less than 3 months
- Patients with a biotherapy treatment by ongoing or less 6 months
Trial locations and contacts
1 site in 1 country.
About this study
IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells predominance, and fibrosis in involved tissues. Despite a preferential involvement of exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are usually effective in this indication, but with poor tolerance and a high risk of relapse after decrease or withdrawal of this treatment. In this context, identification of new therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells are expanded in the blood of these patients. Tfh cells have an important role in the formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell compartment. In this context, this population could have an important contribution in the pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.
TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This study is an exploratory prospective multicentric study. Thirty patients with a suspected diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy sample, will be obtained in this study. The results obtained in patients with a confirmed diagnosis of IgG4-RD (" IgG4-RD group ") will be compared to results of patients with another diagnosis (" control group "). Main objective of the study is to show by confocal microscopy an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1, Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these cells and co-culture tests with autologous naive B cells. All these results will be compared between the " IgG4-RD group " and the " control group ". This study should clarify the role of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and identify therapeutic targets in these patients.
- Conditions
- Disease Immunoglobulin G4
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
One blood sample of 50 milliliter 24 hours after the inclusion
| Study group | Role | What they receive |
|---|---|---|
| diagnosis of disease associated with IgG4 | Experimental | patients suffering from organ initially compatible with a diagnosis of a disease associated with IgG4 Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of TFH cells by immunofluorescence technical
Ratio of TFH cell on the number of total T lymphocytes by high power field in confocal microscopy in tissues of patients
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start14 Feb 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Immunoglobulin G4Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872441
- Sponsor's protocol ID
- 2016-28
- Other IDs
- 2016-A00943-48
- Acronym
- TIFOLH4
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2016
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Tissular T Follicular Helper Cells in IgG4-RD
- ClinicalTrials.gov ID
- NCT02872441
- Acronym / sponsor ID
- TIFOLH4 / 2016-28
- Conditions
- Disease Immunoglobulin G4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 19 Aug 2016 (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.
IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells predominance, and fibrosis in involved tissues. Despite a preferential involvement of exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are usually effective in this indication, but with poor tolerance and a high risk of relapse after decrease or withdrawal of this treatment. In this context, identification of new therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells are expanded in the blood of these patients. Tfh cells have an important role in the formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell compartment. In this context, this population could have an important contribution in the pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.
TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This study is an exploratory prospective multicentric study. Thirty patients with a suspected diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy sample, will be obtained in this study. The results obtained in patients with a confirmed diagnosis of IgG4-RD (" IgG4-RD group ") will be compared to results of patients with another diagnosis (" control group "). Main objective of the study is to show by confocal microscopy an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1, Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these cells and co-culture tests with autologous naive B cells. All these results will be compared between the " IgG4-RD group " and the " control group ". This study should clarify the role of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and identify therapeutic targets in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnosis of disease associated with IgG4 | Experimental | Biological: blood samplepatients suffering from organ initially compatible with a diagnosis of a disease associated with IgG4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with a diagnosis of disease associated with IgG4
- Patient signed a consent
- Patient affiliated to the social security scheme
Key exclusion criteria (3 listed)
- Patients with a corticosteroid therapy current or less than 3 months.
- Patients with an immunosuppressive treatment or being less than 3 months
- Patients with a biotherapy treatment by ongoing or less 6 months
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 |
|---|---|---|
| blood sampleOne blood sample of 50 milliliter 24 hours after the inclusion | Biological | diagnosis of disease associated with IgG4 |
Primary outcome
Location of TFH cells by immunofluorescence technical
Time frame: 36 months
Ratio of TFH cell on the number of total T lymphocytes by high power field in confocal microscopy in tissues of patients
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 30 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Disease Immunoglobulin G4, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 3 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 30 Oct 2023. 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?
Location of TFH cells by immunofluorescence technical (time frame: 36 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 30 Oct 2023.