Langerhans Cell Histiocytosis in Adults: a Collaborative, Prospective-retrospective, Observational GIMEMA Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
RECRUITING
Cagliari
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
RECRUITING
Catania
Fondazione Irccs Istituto Nazionale Tumori - Milano - Sc Ematologia
RECRUITING
Milan
Ao Regionale S. Carlo - Potenza - Sic Ematologia
RECRUITING
Potenza
Fondazione Policlinico Universitario Agostino Gemelli Irccs
RECRUITING
Roma
Università Degli Studi Di Roma Sapienza - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
RECRUITING
Roma
Aou San Giovanni Di Dio E Ruggi D'Aragona - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
RECRUITING
Salerno
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
RECRUITING
Sassari
Contact Information
Primary
Paola Fazi
p.fazi@gimema.it
06 70390528
Backup
Enrico Crea
e.crea@gimema.it
06 70390515
Time Frame
Start Date: 2021-03-15
Estimated Completion Date: 2024-03
Participants
Target number of participants: 186
Treatments
LCH Patients
Adult patients with LCH, diagnosed starting from January 2001
Sponsors
Leads: Gruppo Italiano Malattie EMatologiche dell'Adulto

This content was sourced from clinicaltrials.gov