Examination of the molecular profile in adolescent patients with histiocytic cell hyperplasia, and if a specific mutation is detected, its monitoring.Determination clinical benefit of use fludeoxyglucose (18F-FDG) in PET/CT imagining in with histiocytosis

Phase 1

• Conditions: histiocytic cell proliferation; MedDRA version: 21.1Level: PTClassification code 10069698Term: Langerhans' cell histiocytosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10078782Term: Langerhans cell sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10060801Term: Erdheim-Chester diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10063397Term: Rosai-Dorfman syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2020-005051-20-PL
• Lead Sponsor: Institute of Mother and Child

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-12
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Patient under 18 years of age at the time of inclusion.
2.Histopatologically confirmed or suspected histiocytosis (based on prior test results).
3.Signing of informed consent for trial participation according with current legal regulations.

Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Lack of inclusion criteria.
2.Pregnancy.
3.Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator’s opinion, disqualify a patient from participating in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified