PheochromocytomaHEPHESTOSNCT06444607
Hereditary Pheochromocytoma Assessment of Tumour Immunologies
An observational study of Pheochromocytoma and Paraganglioma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- Venepuncture
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Marieke de Laat, MD, PhD, 24364599 ext. +31, marieke.delaat@radboudumc.nl
Henri Timmers, MD, PhD, 24364599 ext. +31, henri.timmers@radboudumc.nl
About this study
Official title: HEPHESTOS - Hereditary Pheochromocytoma Assessment of Tumour Immunologies
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.
Read the 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 (2,3). Current treatment options, particularly for advanced or metastatic disease, are limited (4). Understanding the immune system's 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 parameters/endpoints: 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.
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- Venepuncture
- Keywords
- Pheochromocytoma, Paraganglioma, Tumor microenvironment, Innate immunity
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureProcedure or surgery
Blood draw in the context of routine patient care, when a venipuncture is already scheduled.
VenepunctureProcedure or surgery
Volunteering for blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hereditary PPGL | Blood will be collected prior and after surgery for their pheochromocytoma/paraganglioma (as planned by their treating physician). Blood will also be collected prospectively during regular follow-up appointments after 1 year and after 2 years. Receives: Procedure: Venepuncture | |
| Patients with sporadic PPGL | Blood will be collected prior and after surgery for their pheochromocytoma/paraganglioma (as planned by their treating physician). Blood will also be collected prospectively during regular follow-up appointments after 1 year and after 2 years. Receives: Procedure: Venepuncture | |
| Asymptomatic carriers of germline mutations predisposing for PPGL | Blood will be collected at inclusion, after 1 year and after 2 years. Receives: Procedure: Venepuncture | |
| Sex and age matched healthy volunteers | Blood material will be obtained from healthy anonymous donors according to the protocol "Donation of blood by healthy volunteers for experimental in-vitro research" (Human Subjects Review Board approval number: NL84281.091.23). Receives: Procedure: Venepuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Immune cell composition in histological PPGL specimens and in circulation.
Measured: Before surgery, 6 weeks after surgery, after 1 year, after 2 years. Histological specimens will only be obtained during surgery.
Secondary outcomes (6)
Transcriptional and epigenetic signature of circulating immune cells.
Measured: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Concentration of immunomodulating metabolites in circulation.
e.g. catecholamines, succinate.
Measured: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Trained immunity assessment of circulating immune cells.
Measured: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Tumour recurrence rate
Measured: After 1 year, after 2 years.
Metastasis rate
Measured: Before surgery, after 1 year, after 2 years.
Survival rate
Measured: After 1 year, after 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margo Dona, PhD, Principal investigator, Radboud University Medical CenterHenri Timmers, M.D. PhD, Principal investigator, Radboud University Medical CenterRomana Netea-Maier, M.D. PhD, Principal investigator, Radboud University Medical CenterMarieke de Laat, M.D. PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444607
- Sponsor's protocol ID
- 115703
- Acronym
- HEPHESTOS
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available by the corresponding author upon reasonable request.
Publications
Lenders JW, Eisenhofer G, Mannelli M, Pacak K. Phaeochromocytoma. Lancet. 2005 Aug 20-26;366(9486):665-75. doi: 10.1016/S0140-6736(05)67139-5.
PubMed 16112304Cascon A, Calsina B, Monteagudo M, Mellid S, Diaz-Talavera A, Curras-Freixes M, Robledo M. Genetic bases of pheochromocytoma and paraganglioma. J Mol Endocrinol. 2023 Jan 24;70(3):e220167. doi: 10.1530/JME-22-0167. Print 2023 Apr 1.
PubMed 36520714Jhawar S, Arakawa Y, Kumar S, Varghese D, Kim YS, Roper N, Elloumi F, Pommier Y, Pacak K, Del Rivero J. New Insights on the Genetics of Pheochromocytoma and Paraganglioma and Its Clinical Implications. Cancers (Basel). 2022 Jan 25;14(3):594. doi: 10.3390/cancers14030594.
PubMed 35158861Nolting S, Bechmann N, Taieb D, Beuschlein F, Fassnacht M, Kroiss M, Eisenhofer G, Grossman A, Pacak K. Personalized Management of Pheochromocytoma and Paraganglioma. Endocr Rev. 2022 Mar 9;43(2):199-239. doi: 10.1210/endrev/bnab019.
PubMed 34147030Tufton N, Hearnden RJ, Berney DM, Drake WM, Parvanta L, Chapple JP, Akker SA. The immune cell infiltrate in the tumour microenvironment of phaeochromocytomas and paragangliomas. Endocr Relat Cancer. 2022 Sep 19;29(11):589-598. doi: 10.1530/ERC-22-0020. Print 2022 Nov 1.
PubMed 35975974Gao X, Yamazaki Y, Pecori A, Tezuka Y, Ono Y, Omata K, Morimoto R, Nakamura Y, Satoh F, Sasano H. Histopathological Analysis of Tumor Microenvironment and Angiogenesis in Pheochromocytoma. Front Endocrinol (Lausanne). 2020 Nov 10;11:587779. doi: 10.3389/fendo.2020.587779. eCollection 2020.
PubMed 33244312van der Heijden CDCC, Groh L, Keating ST, Kaffa C, Noz MP, Kersten S, van Herwaarden AE, Hoischen A, Joosten LAB, Timmers HJLM, Netea MG, Riksen NP. Catecholamines Induce Trained Immunity in Monocytes In Vitro and In Vivo. Circ Res. 2020 Jul 3;127(2):269-283. doi: 10.1161/CIRCRESAHA.119.315800. Epub 2020 Apr 3.
PubMed 32241223
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEPHESTOS - Hereditary Pheochromocytoma Assessment of Tumour Immunologies
- ClinicalTrials.gov ID
- NCT06444607
- Acronym / sponsor ID
- HEPHESTOS / 115703
- Conditions
- Pheochromocytoma, Paraganglioma
- Keywords
- Pheochromocytoma, Paraganglioma, Tumor microenvironment, Innate immunity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (2,3). Current treatment options, particularly for advanced or metastatic disease, are limited (4). Understanding the immune system's 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 parameters/endpoints: 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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with hereditary PPGL | – | Procedure: VenepunctureBlood will be collected prior and after surgery for their pheochromocytoma/paraganglioma (as planned by their treating physician). Blood will also be collected prospectively during regular follow-up appointments after 1 year and after 2 years. |
| Patients with sporadic PPGL | – | Procedure: VenepunctureBlood will be collected prior and after surgery for their pheochromocytoma/paraganglioma (as planned by their treating physician). Blood will also be collected prospectively during regular follow-up appointments after 1 year and after 2 years. |
| Asymptomatic carriers of germline mutations predisposing for PPGL | – | Procedure: VenepunctureBlood will be collected at inclusion, after 1 year and after 2 years. |
| Sex and age matched healthy volunteers | – | Procedure: VenepunctureBlood material will be obtained from healthy anonymous donors according to the protocol "Donation of blood by healthy volunteers for experimental in-vitro research" (Human Subjects Review Board approval number: NL84281.091.23). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
- Aged > 18 years.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenepunctureBlood draw in the context of routine patient care, when a venipuncture is already scheduled. | Procedure or surgery | Asymptomatic carriers of germline mutations predisposing for PPGL, Patients with hereditary PPGL, Patients with sporadic PPGL |
| VenepunctureVolunteering for blood draw. | Procedure or surgery | Sex and age matched healthy volunteers |
Primary outcome
Immune cell response in circulation, both after stimulation and in an unstimulated state, measured as the concentration of inflammatory molecules and proteins.
Time frame: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
e.g. cytokines
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.
6 secondary outcomes
Transcriptional and epigenetic signature of circulating immune cells.
Time frame: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Concentration of immunomodulating metabolites in circulation.
Time frame: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Trained immunity assessment of circulating immune cells.
Time frame: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
Tumour recurrence rate
Time frame: After 1 year, after 2 years.
Metastasis rate
Time frame: Before surgery, after 1 year, after 2 years.
Survival rate
Time frame: After 1 year, after 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 16112304Lenders JW, Eisenhofer G, Mannelli M, Pacak K. Phaeochromocytoma. Lancet. 2005 Aug 20-26;366(9486):665-75. doi: 10.1016/S0140-6736(05)67139-5.
- Background: PubMed 36520714Cascon A, Calsina B, Monteagudo M, Mellid S, Diaz-Talavera A, Curras-Freixes M, Robledo M. Genetic bases of pheochromocytoma and paraganglioma. J Mol Endocrinol. 2023 Jan 24;70(3):e220167. doi: 10.1530/JME-22-0167. Print 2023 Apr 1.
- Background: PubMed 35158861Jhawar S, Arakawa Y, Kumar S, Varghese D, Kim YS, Roper N, Elloumi F, Pommier Y, Pacak K, Del Rivero J. New Insights on the Genetics of Pheochromocytoma and Paraganglioma and Its Clinical Implications. Cancers (Basel). 2022 Jan 25;14(3):594. doi: 10.3390/cancers14030594.
- Background: PubMed 34147030Nolting S, Bechmann N, Taieb D, Beuschlein F, Fassnacht M, Kroiss M, Eisenhofer G, Grossman A, Pacak K. Personalized Management of Pheochromocytoma and Paraganglioma. Endocr Rev. 2022 Mar 9;43(2):199-239. doi: 10.1210/endrev/bnab019.
- Background: PubMed 35975974Tufton N, Hearnden RJ, Berney DM, Drake WM, Parvanta L, Chapple JP, Akker SA. The immune cell infiltrate in the tumour microenvironment of phaeochromocytomas and paragangliomas. Endocr Relat Cancer. 2022 Sep 19;29(11):589-598. doi: 10.1530/ERC-22-0020. Print 2022 Nov 1.
- Background: PubMed 33244312Gao X, Yamazaki Y, Pecori A, Tezuka Y, Ono Y, Omata K, Morimoto R, Nakamura Y, Satoh F, Sasano H. Histopathological Analysis of Tumor Microenvironment and Angiogenesis in Pheochromocytoma. Front Endocrinol (Lausanne). 2020 Nov 10;11:587779. doi: 10.3389/fendo.2020.587779. eCollection 2020.
- Background: PubMed 32241223van der Heijden CDCC, Groh L, Keating ST, Kaffa C, Noz MP, Kersten S, van Herwaarden AE, Hoischen A, Joosten LAB, Timmers HJLM, Netea MG, Riksen NP. Catecholamines Induce Trained Immunity in Monocytes In Vitro and In Vivo. Circ Res. 2020 Jul 3;127(2):269-283. doi: 10.1161/CIRCRESAHA.119.315800. Epub 2020 Apr 3.
- Individual participant dataSharing planned: Yes. Data will be made available by the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margo Dona, PhD principal investigator
Radboud University Medical Center
Henri Timmers, M.D. PhD principal investigator
Radboud University Medical Center
Romana Netea-Maier, M.D. PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma and Paraganglioma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Xu, M.D. (+316 42385270, kai.xu@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune cell response in circulation, both after stimulation and in an unstimulated state, measured as the concentration of inflammatory molecules and proteins. (time frame: Before surgery, 6 weeks after surgery, after 1 year, after 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06444607, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.