Hodgkin-biomarkers
- Conditions
- Pediatric Hodgkin lymphoma
- Registration Number
- NL-OMON28180
- Lead Sponsor
- Erasmus MC - Sophia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
Hodgkin lymphoma group
In order to be eligible to participate in the Hodgkin lymphoma group, a subject must meet all of the following criteria:
-? Diagnosis of classical Hodgkin Lymphoma confirmed by reference pathology
-? Patient aged below 18 at time of diagnosis
-? Treatment according the European Network of Paediatric Hodgkin`s Lymphoma Second International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents (EuroNet-PHL-C2) protocol or treatment for relapsed or refractory patients.
-? Written informed consent of the patient and/or the patient's parents or guardians according to national laws
Control Group
In order to be eligible to participate in the control group a subject must meet all of the following criteria:
-? No diagnosis of classical Hodgkin Lymphoma confirmed by reference pathology
-? Patient aged below 18 at time of diagnosis
-? Written informed consent of the patient and/or the patient's parents or guardians according to national laws
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-? HIV positivity
-? Other underlying immunologic disorders, with the exception of Epstein Barr Virus
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this project is to identify biomarkers and novel therapeutic targets for pediatric Hodgkin lymphoma.
- Secondary Outcome Measures
Name Time Method To achieve this aim we defined three objectives:<br>1. Hodgkin Reed-Sternberg cells: we intend to perform whole exome sequencing and gene expression arrays of FACS-sorted malignant Hodgkin and Reed-Sternberg cells to get insights in their genetic profile to identify therapeutic targets.<br>2. Tissue microenvironment: we wish to investigate the tumor microenvironment by immunohistochemistry and gene expression profiling of microenvironment-derived T-cells to identify and validate new biomarkers (TARC, PD-1) and therapeutic targets.<br>3. Serum biomarkers: To investigate the value of serum TARC and other biomarkers (see table 1 of the protocol) and levels of cfDNA as disease response markers after each cycle of chemotherapy and directly compare it to the PET scan. We will analyze serum and blood samples after treatment and during follow-up to identify biomarkers for disease recurrence.