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

NCT04627090 | Recruiting

• 1 other identifier: RD0120
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 8

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

Conditions

Langerhans Cell Histiocytosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of efficacy of first-line therapies

  Number of patients who achive complete/intermediate response

  up to 3 months

Study Arms (1)

LCH Patients

Adult patients with LCH, diagnosed starting from January 2001

Other: Data collection

Interventions

Data collection OTHER

Diagnostic and therapeutic data of adult patients with LCH, collected from clinical and laboratory evaluations, carried out during clinical practice.

LCH Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with LCH, diagnosed starting from January 2001 to two years after the first enrolled patient.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (8)

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

Cagliari, Italy

RECRUITING

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

Catania, Italy

RECRUITING

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

Milan, Italy

RECRUITING

Ao Regionale S. Carlo - Potenza - Sic Ematologia

Potenza, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Roma, Italy

RECRUITING

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

Roma, Italy

RECRUITING

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

Salerno, Italy

RECRUITING

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

Sassari, Italy

RECRUITING

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Paola Fazi

CONTACT

06 70390528; p.fazi@gimema.it

Enrico Crea

CONTACT

06 70390515; e.crea@gimema.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 13, 2020
• Study Start: March 15, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IT (8)