GranulomatosisGRAMI-BIONCT06854848
Cohort of Patients With Systemic Granulomatosis and Associated Biological Collection
An observational study of Granulomatosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The GRAMI-BIO study is a prospective single-centre cohort study to recruit 150 patients followed up in the the Bordeaux University Hospital. The total duration of the GRAMI-BIO study is ten years (five years of inclusion with five years of follow-up): Consecutive inclusion of patients meeting the definition of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis
- What is being tested?
- blood sample and urine sample
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling)
Who may be able to join
- Patients aged 18 or over
- Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling) at diagnosis.
- Persons affiliated to or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- Patients infected with human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV)
- Pregnant or breast-feeding women
- Patients already receiving specific treatment for systemic granulomatosis
- Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean DELAUNE contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique
Bordeaux
Emmanuel RIBEIRO, MD, 05.56.79.58.28 ext. +33, emmanuel.ribeiro@chu-bordeaux.fr
Jean DELAUNE, jean.delaune@chu-bordeaux.fr
About this study
Official title: Cohort of Patients With Systemic Granulomatosis (Sarcoidosis and Other Systemic Granulomatoses) and Associated Biological Collection GRAMI-BIO Study
The GRAMI-BIO study is a prospective single-centre cohort study to recruit 150 patients followed up in the the Bordeaux University Hospital. The total duration of the GRAMI-BIO study is ten years (five years of inclusion with five years of follow-up): Consecutive inclusion of patients meeting the definition of systemic granulomatosis. The main objective of this cohort is to describe to clinical progression of systemic granulomatosis and to collect blood fraction samples (serum bank, plasma bank, urine bank, DNA bank) from subjects participating in the cohort.
Read the detailed description
Systemic granulomatosis is a group of diseases whose common feature is the anatomopathological existence of giganto-cellular granulomas composed of macrophages, epithelial cells and CD4+ T lymphocytes. The exact cause of the development of these granulomas remains unknown, although numerous studies suggest the hypothesis of environmental factors (infectious, exposure to particles) and genetic susceptibility factors. The persistence of granulomas is deleterious, ultimately leading to local destruction and tissue damage resulting in fibrosis of neighbouring tissues. Granulomatosis is a heterogeneous group in terms of aetiology: schematically, either an aetiology is identified: infection, environmental factors (berylliosis, pneumoconiosis), iatrogenesis (drugs), neoplasia, immune deficiency; or granulomatosis is said to be idiopathic, the most common case, falling within the definition of systemic sarcoidosis. Therefore, with a view to future research work, it seems imperative to set up a biological bank of patients being monitored for systemic granulomatosis within the division. It is particularly important to identify genetic variants, circulating biomarkers associated with the onset, severity and response to treatment of these diseases. The main aim of the "GRAMI-BIO" study is to describe the clinical evolution of patients with systemic granulomatosis (sarcoidosis and other granulomatoses) followed at the Bordeaux University Hospital, and to collect samples from blood fractionation (serum bank, plasma bank, urine bank, DNA, RNA bank) to constitute a biobank.
- Conditions
- Granulomatosis
- Being tested
- blood sample, urine sample
- Keywords
- Granulomatosis, sarcoidosis, Biological collection
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sampleBiological
10 ml
| Study group | Role | What they receive |
|---|---|---|
| Granulomatosis | Not described Receives: Biological: blood sample; Biological: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the clinical progression of systemic granulomatosis
Measured: At baseline (Day 0) and 60 months after baseline
Secondary outcomes (4)
Identify predictive factors for the progression of the disease
Measured: At baseline (Day 0) and 60 months after baseline
Identify the management methods into patients with systemic granulomatosis
Measured: At baseline (Day 0) and 60 months after baseline
Identify predictive factors for response to treatments
Measured: At baseline (Day 0) and 60 months after baseline
Identify new clusters of the disease in a large population both clinically and biologically
Measured: At baseline (Day 0) and 60 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start4 Dec 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GranulomatosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel RIBEIRO, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854848
- Sponsor's protocol ID
- CHUBX 2024/73
- Acronym
- GRAMI-BIO
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2025
- Last updated
- 3 Feb 2026
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With Systemic Granulomatosis (Sarcoidosis and Other Systemic Granulomatoses) and Associated Biological Collection GRAMI-BIO Study
- ClinicalTrials.gov ID
- NCT06854848
- Acronym / sponsor ID
- GRAMI-BIO / CHUBX 2024/73
- Conditions
- Granulomatosis
- Keywords
- Granulomatosis, sarcoidosis, Biological collection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 3 Mar 2025 (actual)
- 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 GRAMI-BIO study is a prospective single-centre cohort study to recruit 150 patients followed up in the the Bordeaux University Hospital. The total duration of the GRAMI-BIO study is ten years (five years of inclusion with five years of follow-up): Consecutive inclusion of patients meeting the definition of systemic granulomatosis. The main objective of this cohort is to describe to clinical progression of systemic granulomatosis and to collect blood fraction samples (serum bank, plasma bank, urine bank, DNA bank) from subjects participating in the cohort.
Detailed description
Systemic granulomatosis is a group of diseases whose common feature is the anatomopathological existence of giganto-cellular granulomas composed of macrophages, epithelial cells and CD4+ T lymphocytes. The exact cause of the development of these granulomas remains unknown, although numerous studies suggest the hypothesis of environmental factors (infectious, exposure to particles) and genetic susceptibility factors. The persistence of granulomas is deleterious, ultimately leading to local destruction and tissue damage resulting in fibrosis of neighbouring tissues. Granulomatosis is a heterogeneous group in terms of aetiology: schematically, either an aetiology is identified: infection, environmental factors (berylliosis, pneumoconiosis), iatrogenesis (drugs), neoplasia, immune deficiency; or granulomatosis is said to be idiopathic, the most common case, falling within the definition of systemic sarcoidosis. Therefore, with a view to future research work, it seems imperative to set up a biological bank of patients being monitored for systemic granulomatosis within the division. It is particularly important to identify genetic variants, circulating biomarkers associated with the onset, severity and response to treatment of these diseases. The main aim of the "GRAMI-BIO" study is to describe the clinical evolution of patients with systemic granulomatosis (sarcoidosis and other granulomatoses) followed at the Bordeaux University Hospital, and to collect samples from blood fractionation (serum bank, plasma bank, urine bank, DNA, RNA bank) to constitute a biobank.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Granulomatosis | – | Biological: blood sample, Biological: urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling)
Key inclusion criteria (4 listed)
- Patients aged 18 or over
- Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling) at diagnosis.
- Persons affiliated to or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Key exclusion criteria (4 listed)
- Patients infected with human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV)
- Pregnant or breast-feeding women
- Patients already receiving specific treatment for systemic granulomatosis
- Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.
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 sample30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Biological | Granulomatosis |
| urine sample10 ml | Biological | Granulomatosis |
Primary outcome
Describe the clinical progression of systemic granulomatosis
Time frame: At baseline (Day 0) and 60 months after baseline
4 secondary outcomes
Identify predictive factors for the progression of the disease
Time frame: At baseline (Day 0) and 60 months after baseline
Identify the management methods into patients with systemic granulomatosis
Time frame: At baseline (Day 0) and 60 months after baseline
Identify predictive factors for response to treatments
Time frame: At baseline (Day 0) and 60 months after baseline
Identify new clusters of the disease in a large population both clinically and biologically
Time frame: At baseline (Day 0) and 60 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- 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.
Jean DELAUNE contact
Emmanuel RIBEIRO, MD principal investigator
University Hospital, Bordeaux
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 Granulomatosis, run by University Hospital, Bordeaux 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel RIBEIRO, MD (05.56.79.58.28 ext. +33, emmanuel.ribeiro@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the clinical progression of systemic granulomatosis (time frame: At baseline (Day 0) and 60 months after baseline). 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 3 Feb 2026.