Identifying biomarkers in adult Langerhans cell histiocytosis
Biomarqueurs Diagnostiques, Pronostiques et de réponse au Traitement Dans l'Histiocytose Langerhansienne de l'Adulte
Assistance Publique - Hôpitaux de Paris · NCT06197204
This study is trying to see if certain gene changes in blood samples can help doctors better understand and manage Langerhans cell histiocytosis in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 570 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06197204 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult Langerhans cell histiocytosis (LCH), a rare disease characterized by the activation of the MAPK pathway due to specific mutations. The study aims to assess the presence of MAPK mutations in plasma free cell DNA among patients with active systemic LCH and those with single system disease. By analyzing blood samples and biopsies, the research seeks to improve diagnostic and prognostic capabilities for LCH. The findings could lead to better understanding and management of this complex condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed LCH or those with related lung conditions.
Not a fit: Patients under guardianship, pregnant women, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diagnostic accuracy and treatment response monitoring for patients with LCH.
How similar studies have performed: While studies on MAPK mutations in other conditions have shown promise, this specific approach in LCH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: LCH patients : * Age ≥ 18 years * All confirmed LCH seen at the reference center whatever the clinical presentation Controls : * Age ≥ 18 years * Patients with diffuse lung cystic disease, pulmonary emphysema and healthy smokers All : * Signing an informed consent * Patients with health insurance Exclusion Criteria: * Persons under guardianship or curatorship, or deprived of freedom by a judicial or administrative decision. * People benefiting from Medical Aid from the State (AME) * Pregnant women, parturient and mothers who are breastfeeding. * Persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than research * Persons unable to express their consent
Where this trial is running
Paris
- Hopital Saint Louis — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Abdellatif Tazi, Pr
- Email: abdellatif.tazi@aphp.fr
- Phone: +33142499618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Histiocytosis, Langerhans-Cell