LCH in Adults: a Collaborative, Prospective-retrospective, Observational Study
- Conditions
- Langerhans Cell Histiocytosis
- Interventions
- Other: Data collection
- Registration Number
- NCT04627090
- Brief Summary
This is a multicenter, retrospective and prospective, observational, no profit study including adult patients with LCH, diagnosed starting from January 2001 to two years after the first enrolled patient. Each patient will be followed up to one year after the last enrolled patient. Each patient will be followed up to one year after the last enrolled patient.This study plans to collect clinical information at the time of diagnosis and at various follow-ups to evaluate the efficacy of first-line therapies. Diagnostic and therapeutic data will be collected from routine clinical evaluations and laboratory and instrumental investigations carried out during clinical practice
- Detailed Description
This is a multicenter, retrospective and prospective, observational, no profit study including adult patients with LCH, diagnosed starting from January 2001 to two years after the first enrolled patient. Data from patients, diagnosed from January 2001 to the date of patient enrolment, is considered retrospective, while data collected after patient enrolment, and up to two years after the first enrolled patient, is considered prospective. At least one year of follow-up is expected for each patient. Each patient will be followed up to one year after the last enrolled patient. This study plans to collect clinical information at the time of diagnosis and at various follow-ups to evaluate the efficacy of first-line therapies. Diagnostic and therapeutic data will be collected from routine clinical evaluations and laboratory and instrumental investigations carried out during clinical practice. A sub-cohort of patients with available biological data on somatic mutations of the RAF-MEK-ERK genes will also be evaluated.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 186
- Confirmed histological and immunohistochemical diagnosis of LCH (CD1a+, S-100+, CD207+), from January 2001 up to two years after the first enrolled patient. Patients with isolated vertebra plana, not related to a malignancy, and without a soft tissue component, are included without a histological and immunohistochemical diagnosis;
- Age ≥18 years at the time of definitive diagnosis;
- Signed, written informed consent, according to ICH/EU/GCP, and national, local laws.
- Age ≥18 years and presumptive diagnosis of LCH, or definitive diagnosis of non-Langerhans Histiocytosis (Juvenile xantogranuloma, Rosai-Dorfman disease, Erdheim-Chester disease, etc.).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LCH Patients Data collection Adult patients with LCH, diagnosed starting from January 2001
- Primary Outcome Measures
Name Time Method Evaluation of efficacy of first-line therapies up to 3 months Number of patients who achive complete/intermediate response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
🇮🇹Cagliari, Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
🇮🇹Catania, Italy
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
🇮🇹Milano, Italy
Ao Regionale S. Carlo - Potenza - Sic Ematologia
🇮🇹Potenza, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
🇮🇹Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
🇮🇹Roma, Italy
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
🇮🇹Salerno, Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
🇮🇹Sassari, Italy