LCH in Adults: a Collaborative, Prospective-retrospective, Observational Study

Last updated: February 6, 2024
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Cancer

Treatment

Data collection

Clinical Study ID

NCT04627090
RD0120
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Confirmed histological and immunohistochemical diagnosis of LCH (CD1a+, S-100+,CD207+), from January 2001 up to two years after the first enrolled patient. Patientswith isolated vertebra plana, not related to a malignancy, and without a soft tissuecomponent, 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.

Exclusion

Exclusion Criteria:

  • Age ≥18 years and presumptive diagnosis of LCH, or definitive diagnosis ofnon-Langerhans Histiocytosis (Juvenile xantogranuloma, Rosai-Dorfman disease,Erdheim-Chester disease, etc.).

Study Design

Total Participants: 186
Treatment Group(s): 1
Primary Treatment: Data collection
Phase:
Study Start date:
March 15, 2021
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

    Cagliari,
    Italy

    Active - Recruiting

  • Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania

    Catania,
    Italy

    Active - Recruiting

  • Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia

    Milano,
    Italy

    Active - Recruiting

  • Ao Regionale S. Carlo - Potenza - Sic Ematologia

    Potenza,
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma,
    Italy

    Active - Recruiting

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma,
    Italy

    Active - Recruiting

  • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche

    Salerno,
    Italy

    Active - Recruiting

  • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia

    Sassari,
    Italy

    Active - Recruiting

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