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Pheochromocytoma clinical trials

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NCT ID: NCT06440122 Recruiting - Pheochromocytoma Clinical Trials

The Incidence and Outcomes of Metabolically Active Brown Adipose Tissue (aBAT) in Patients With Pheochromocytoma or Paraganglioma (PPGLs)

Start date: May 31, 2024
Phase:
Study type: Observational

White adipose tissue (WAT) and brown adipose tissue (BAT) form the main adipose tissue subtypes in humans and several animals. BAT, owing to its unique metabolic function, has been of increased focus and interest in metabolic research (1). BAT forms the major organ of non-shivering thermogenesis in the body, and is dependent on the large concentration of mitochondria and increased uncoupling protein-1 (UCP-1) activity present in this type of tissue (2). There are numerous triggers for the metabolic activation of BAT including cold temperature, low body mass index (BMI), adrenergic agonists, and elevated concentration of thyroid hormones (3). BAT is found more abundantly in fetuses and infants, with significant regression into adulthood. The main areas where BAT can be found are the neck, mediastinum, axilla, retroperitoneum, and abdominal wall (4). Clinical research suggests that activation and thermogenesis in BAT are mediated by noradrenaline release from the sympathetic nervous system (5). With the increasing use of fluorodeoxyglucose positron emission tomography (18FDG-PET) imaging, there has been an increased detection rate of activated brown adipose tissue (aBAT); this may affect diagnoses and lead to false-positive reporting (6). Phaeochromocytomas/paragangliomas (PPGLs) are chromaffin-cell-derived endocrine tumors that emerge from the adrenal medulla or extra-adrenal ganglia. High FDG accumulation has been commonly noted in aBAT in patients with catecholamine-producing tumours, with subsequent resolution of these findings after resection of the tumour (7). This finding is likely related to the increased glucose transport related to noradrenaline excess (4). BAT has traditionally been considered to mainly express β3-adrenoreceptors; however, in vitro studies have indicated that activated β2-adrenoreceptors may be the main driving force behind thermogenesis (8). Studies reviewing PPGLs have shown an aBAT detection rate of 7.8% to 42.8% on FDG-PET imaging, correlating with elevated catecholamine levels but without clear correlation to germline mutations (9-12). In one study, this imaging finding was associated with a statistically significant reduction in overall survival (12). Standardisation for the 'standardised uptake value' (SUV) cut-offs for aBAT on FDG-PET are lacking, but these are often reported between 1.0 and 2.0 (13); in previous studies of PPGL, a cut-off value of >1.5 has been employed (10, 12). Research on the clinical implications of aBAT in patients with PPGL remains scarce. The main objectives of this study were to gain further insights into BAT activation rates in patients with PPGLs and how this may relate to patient demographics, biochemistry, radiological features, mutational status, and outcomes. The main hypotheses were that aBAT rates would be significantly linked to the severity of catecholamine excess and could be considered a poor prognostic feature.

NCT ID: NCT06429397 Recruiting - Pheochromocytoma Clinical Trials

First-line Anlotinib Combined With Penpulimab for Advanced Pheochromocytoma: A Single-arm, Multicenter, Prospective Phase II Study

Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.

NCT ID: NCT06377033 Recruiting - Parkinson Disease Clinical Trials

Using the EHR to Advance Genomic Medicine Across a Diverse Health System

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place. Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.

NCT ID: NCT06229405 Recruiting - Pheochromocytoma Clinical Trials

Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data

Start date: May 10, 2022
Phase:
Study type: Observational [Patient Registry]

This research aims to establish clinical evidence for optimal treatment guidelines for adrenal diseases using real-world data. The approach involves building prospective and retrospective patient registries, which will be utilized to develop and conduct research on disease-specific protocols for adrenal disorders. The study targets patients with primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion. Registries for patients with adrenal diseases will be obtained from Seoul National University Hospital and Asan Medical Center, along with securing a common data model. The ultimate goal is to conduct research to generate clinical evidence for adrenal diseases using these resources.

NCT ID: NCT06062082 Recruiting - Pheochromocytoma Clinical Trials

Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

HEMODADRE
Start date: September 1, 2015
Phase:
Study type: Observational

Pheochromocytomas are tumors of the adrenal gland that develop from cells producing adrenaline and noradrenaline. Consequently, intraoperative blood pressure variations (hypertensive and hypotensive episodes) are characteristic of pheochromocytoma surgery, when these tumors are removed. However, recommendations for the management of these tumors are based on data essentially dating from the 1960s-1990s. Since then, anesthesia and surgery for patients with pheochromocytoma have evolved considerably, and have become more effective with time. In these circumstances, a review of the current situation is necessary. The aim of this study is to investigate the intraoperative hemodynamic changes observed in patients undergoing adrenalectomy for pheochromocytoma, comparing them with the hemodynamic profile observed in patients undergoing adrenal surgery for a pathology other than pheochromocytoma (control group).

NCT ID: NCT06050057 Recruiting - Pheochromocytoma Clinical Trials

Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy

Start date: September 3, 2023
Phase:
Study type: Observational

The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are: 1. to find the superiority of one the the surgical method mentioned above 2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

NCT ID: NCT06015061 Recruiting - Ultrasonography Clinical Trials

Prediction and Evaluation of Anlotinib Treatment Response Using Contrast Enhanced Ultrasound PPGL Patients

Start date: March 1, 2023
Phase:
Study type: Observational

Anlotinib is a multi-target receptor tyrosine kinase inhibitor (TKI) targeting tumor angiogenesis and growth. The purpose of this study is to evaluate the efficiency of contrast enhanced ultrasound in assessing effectiveness of anlotinib in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma(PPGL).

NCT ID: NCT05944237 Recruiting - Neoplasms Clinical Trials

HTL0039732 in Participants With Advanced Solid Tumours

Start date: July 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

NCT ID: NCT05885399 Recruiting - Clinical trials for Paraganglioma, Malignant

The Efficacy and Safety of Penpulimab in the Treatment of Metastatic PPGL Patients Who Fail to Other Systemic Treatment

Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

Metastatic pheochromocytoma / paraganglioma (MPP) are rare while the prognosis was poor. Penpulimab is specifically an immune check-point inhibitor of PD1 and has been approved for the treatment of several malignancies.This phase II trial studies the efficacy and safety of penpulimab in the treatment of MPP patients who fail to other systemic therapy.

NCT ID: NCT05885386 Recruiting - Pheochromocytoma Clinical Trials

A Study on the Safety and Effectiveness of Temozolomide for Neoadjuvant Treatment of PPGL

Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effectiveness oftemozolomide in the neoadjuvant therapy oflocally advanced,or unresectable pheochromocytoma or paragangliom(PPGL). Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. Inthisstudy,temozolomidewill be used preoperatively in order to change unresectable tumors to resectable and reduce the high risk of surgery.