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Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging — HISTIOGEN  

Histiocytosis Clinical Trial

Official title:
Determination of Molecular Status, as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis

Clinical Trial Summary

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.

Clinical Trial Description

HISTIOGEN clinical study is part of the POLHISTIO project. The POLHISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis. The project objectives are defined as follows: 1) to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA; 2) to compare molecular test results with clinical data; 3) to evaluate the diagnostic usefulness of the status of molecular analysis (MRD) as a prognostic factor compared with other recognized factors. As part of the HISTIOGEN protocol, an immortalized cell line will be derived to study the pathogenesis of the disease, drug sensitivity, and drug resistance mechanisms. The project is intended to include patients from all over Poland ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04943211
Study type Interventional
Source Institute of Mother and Child, Warsaw, Poland
Contact Katarzyna Maleszewska
Phone +48 22 32 77 205
Email klinika.onkologii@imid.med.pl
Status Recruiting
Phase Phase 3
Start date April 1, 2021
Completion date June 23, 2026
View Details
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