Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444607
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-22
Brief Title:
Hereditary Pheochromocytoma Assessment of Tumour Immunologies
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
HEPHESTOS - Hereditary Pheochromocytoma Assessment of Tumour Immunologies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPHESTOS
Brief Summary:
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
Detailed Description:
Rationale Pheochromocytoma and Paraganglioma PPGL represent rare catecholamine-secreting tumours 1 Genetic or sporadic mutations accounting for approximately 70 of cases significantly contribute to PPGL development and are categorized into three clusters based on tumour formation mechanisms 23 Current treatment options particularly for advanced or metastatic disease are limited 4 Understanding the immune systems role and the impact of genetics on tumour immunology in PPGL could unveil crucial insights for therapeutic advancements Earlier studies emphasized the immunogenic nature of PPGL highlighting the tumour microenvironment TME and circulatory factors as key components 5-7 However these studies lack specific examination of genotypes effect on the immune system This study aims to address this gap in two parts particularly focusing on differences between genetic clusters
Objective To examine the differences in the immune system in PPGL regarding genetics Part I will examine immune cell composition and response in circulation Part II will examine immune cell composition in TME
Study design Part I will be a partly cross-sectional and partly prospective cohort study Part II will be a histological study of retrospectively and prospectively collected PPGL samples
Study population Part I will include 80 patients with PPGL 80 carriers of germline mutations predisposing for PPGL and 40 sex and age matched healthy volunteers Part II will include histological samples of 80 patients with hereditary disease and 80 patients with sporadic disease
Main study parametersendpoints The main study outcomes are inflammatory molecules and proteins produced by stimulated and unstimulated immune cells from circulation immune cell composition in histological PPGL samples and in circulation and their genetic determinants Secondary outcomes will comprise of transcriptional and epigenetic signature of circulating immune cells circulating immunomodulating metabolites trained immunity and clinical outcomes such as tumour metastasis survival
Nature and extent of the burden and risks associated with participation benefit and group relatedness For patients and mutation carriers there is no direct benefit in participating in this study However by participating they can contribute to the acquisition of scientific knowledge and the development of new therapeutic targets and novel disease management strategies Such strategies might benefit patients and mutation carriers in the future if they potentially develop advanced disease There are no risks associated with the study There are no interventions other than those related to the regular patient care venipuncture Thus this study is considered to impose a low burden on patients
Objective To examine the differences in the immune system in PPGL regarding genetics Part I will examine immune cell composition and response in circulation Part II will examine immune cell composition in TME
Study design Part I will be a partly cross-sectional and partly prospective cohort study Part II will be a histological study of retrospectively and prospectively collected PPGL samples
Study population Part I will include 80 patients with PPGL 80 carriers of germline mutations predisposing for PPGL and 40 sex and age matched healthy volunteers Part II will include histological samples of 80 patients with hereditary disease and 80 patients with sporadic disease
Main study parametersendpoints The main study outcomes are inflammatory molecules and proteins produced by stimulated and unstimulated immune cells from circulation immune cell composition in histological PPGL samples and in circulation and their genetic determinants Secondary outcomes will comprise of transcriptional and epigenetic signature of circulating immune cells circulating immunomodulating metabolites trained immunity and clinical outcomes such as tumour metastasis survival
Nature and extent of the burden and risks associated with participation benefit and group relatedness For patients and mutation carriers there is no direct benefit in participating in this study However by participating they can contribute to the acquisition of scientific knowledge and the development of new therapeutic targets and novel disease management strategies Such strategies might benefit patients and mutation carriers in the future if they potentially develop advanced disease There are no risks associated with the study There are no interventions other than those related to the regular patient care venipuncture Thus this study is considered to impose a low burden on patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None