Hereditary Pheochromocytoma Assessment of Tumour Immunologies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
In this study, the investigators are examining the role of the immune system in pheochromocytoma and paraganglioma. The investigators aim to examine the differences in the immune system between people who have these tumors with and without a hereditary predisposition. The investigators also want to see how the immune system changes during the development of the tumor in people with a hereditary predisposition. Finally, the investigators will compare the data with a control group of people without these tumors. Ultimately, the investigators hope that the results will contribute to the discovery of new immune system-targeted medications for pheochromocytoma and paraganglioma.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Newly diagnosed patients with PPGL or newly diagnosed patients with (metastatic) PPGL recurrence.
OR patients with mutations which predispose for the development of PPGL.
Aged > 18 years.
Confirmed PPGL on pathology.
Disqualifiers
Unable to provide informed consent.
Active inflammatory or infectious comorbidities.
Other malignancies which are under active treatment (except for basal cell carcinoma, other in situ carcinomas).
Using medication interfering with the immune system
Trial population
For part I, the study population will consist of patients who are presenting or are currently under follow-up at the Radboudumc endocrinology department for their PPGL. Eigthy patients will be included with hereditary or sporadic cases of PPGL and an equal number of asymptomatic carriers. The healthy control group will consist of 40 age and sex matched healthy volunteers. Part II will include histological samples of 160 patients with PPGL, of which 80 hereditary and 80 sporadic. A large part of the population will overlap between part I and part II, since almost all patients with PPGL undergo surgery for their tumour. These samples will partly be retrospectively collected from the Radboudumc Urology Biobank, where biomaterials from previously treated patients with PPGLs are kept and stored or future scientific research (Human Subjects Review Board approval number: CWOM-9803-0060). The remaining samples will be collected prospectively from patients undergoing surgery for their PPGL.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Venepuncture
Procedure/SurgeryBlood draw in the context of routine patient care, when a venipuncture is already scheduled.
Venepuncture
Procedure/SurgeryVolunteering for blood draw.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Patients with hereditary PPGL1 intervention
Group B: Patients with sporadic PPGL1 intervention
Group C: Asymptomatic carriers of germline mutations predisposing for PPGL1 intervention
Group D: Sex and age matched healthy volunteers1 intervention
Trial outcomes
Primary outcomes
1
Immune cell response in circulation, both after stimulation and in an unstimulated state, measured as the concentration of inflammatory molecules and proteins.
e.g. cytokines
Time frame
Before surgery, 6 weeks after surgery, after 1 year, after 2 years.2
Immune cell composition in histological PPGL specimens and in circulation.
Time frame
Before surgery, 6 weeks after surgery, after 1 year, after 2 years. Histological specimens will only be obtained during surgery.Secondary outcomes
1
Transcriptional and epigenetic signature of circulating immune cells.
Time frame
Before surgery, 6 weeks after surgery, after 1 year, after 2 years.2
Concentration of immunomodulating metabolites in circulation.
e.g. catecholamines, succinate.
Time frame
Before surgery, 6 weeks after surgery, after 1 year, after 2 years.3
Trained immunity assessment of circulating immune cells.
Time frame
Before surgery, 6 weeks after surgery, after 1 year, after 2 years.4
Tumour recurrence rate
Time frame
After 1 year, after 2 years.Sponsors and contacts
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Source ClinicalTrials.gov