Determination of Molecular Status, as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis
Overview
- Phase
- Phase 3
- Intervention
- fluorodeoxyglucose (18F-FDG)
- Conditions
- Histiocytosis
- Sponsor
- Anna Raciborska
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- EFS - (event-free survival)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Detailed 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
Investigators
Anna Raciborska
Prof Ass
Institute of Mother and Child, Warsaw, Poland
Eligibility Criteria
Inclusion Criteria
- •Patient under 18 years of age at the time of inclusion.
- •Histopathologically confirmed or suspected histiocytosis (based on prior test results).
- •Signing of informed consent for trial participation according with current legal regulations.
Exclusion Criteria
- •Lack of inclusion criteria.
- •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.
Arms & Interventions
R1 low intervention arm
Children of both sexes who meet all inclusion criteria and do not meet any exclusion criteria will be eligible for the study.
Intervention: fluorodeoxyglucose (18F-FDG)
Outcomes
Primary Outcomes
EFS - (event-free survival)
Time Frame: 2 years
Event-free survival (EFS) was defined as the time interval from the date of diagnosis to the date of disease progression, recurrence, second malignancy, death or to date of last follow-up for patients without events.
Secondary Outcomes
- OS (Overall Survival)(2 years)
- Molecular relapse (in ct DNA)(2 years)