Examining the immune system in hereditary pheochromocytoma and paraganglioma
HEPHESTOS - Hereditary Pheochromocytoma Assessment of Tumour Immunologies
Radboud University Medical Center · NCT06444607
This study is testing how the immune system works in people with pheochromocytoma and paraganglioma, especially those with a family history of these tumors, to see if it can help us find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06444607 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of the immune system in patients with pheochromocytoma and paraganglioma, focusing on differences between those with hereditary predispositions and those without. The study is divided into two parts: the first part analyzes immune cell composition and response in circulation, while the second part examines immune cell composition within the tumor microenvironment. A total of 80 patients with pheochromocytoma, 80 carriers of germline mutations, and 40 healthy volunteers will be included. The findings aim to enhance understanding of tumor immunology and potentially lead to new immune-targeted therapies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with newly diagnosed pheochromocytoma or paraganglioma, or those with genetic mutations predisposing them to these tumors.
Not a fit: Patients with active inflammatory or infectious comorbidities, other malignancies under active treatment, or those using medications that interfere with the immune system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new immune system-targeted medications for pheochromocytoma and paraganglioma.
How similar studies have performed: Previous studies have highlighted the immunogenic nature of pheochromocytoma and paraganglioma, but this specific examination of genetic influences on the immune system is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Part I: * 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. Part II: * Confirmed PPGL on pathology. * Aged \> 18 years. Exclusion Criteria: * 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 * Pregnancy or breastfeeding * A self-reported alcohol consumption of \>21 units per week
Where this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Margo Dona, PhD — Radboud University Medical Center
- Study coordinator: Kai Xu, M.D.
- Email: kai.xu@radboudumc.nl
- Phone: +316 42385270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pheochromocytoma, Paraganglioma, Tumor microenvironment, Innate immunity