NCT06854848

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
117mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Dec 2025Dec 2035

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

December 4, 2025

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

February 25, 2025

Last Update Submit

January 30, 2026

Conditions

Granulomatosis

Keywords

GranulomatosissarcoidosisBiological collection

Outcome Measures

Primary Outcomes (1)

  • Describe the clinical progression of systemic granulomatosis

    At baseline (Day 0) and 60 months after baseline

Secondary Outcomes (4)

  • Identify predictive factors for the progression of the disease

    At baseline (Day 0) and 60 months after baseline

  • Identify the management methods into patients with systemic granulomatosis

    At baseline (Day 0) and 60 months after baseline

  • Identify predictive factors for response to treatments

    At baseline (Day 0) and 60 months after baseline

  • Identify new clusters of the disease in a large population both clinically and biologically

    At baseline (Day 0) and 60 months after baseline

Study Arms (1)

Granulomatosis

Biological: blood sampleBiological: urine sample

Interventions

blood sampleBIOLOGICAL

30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Granulomatosis
urine sampleBIOLOGICAL

10 ml

Granulomatosis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique

Bordeaux, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and 10 ml urine sample.

MeSH Terms

Conditions

Sarcoidosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Emmanuel RIBEIRO, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel RIBEIRO, MD

CONTACT

05.56.79.58.28emmanuel.ribeiro@chu-bordeaux.fr

Jean DELAUNE

CONTACT

jean.delaune@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

December 4, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)