Clinical Research Directory

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Background: * Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. * Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. * The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. * Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: * All patients age greater than or equal to 2 years with malignant mesothelioma * Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: * Up to 1000 subjects will be enrolled. * Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. * Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. * Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies....

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

This nationwide, multicenter, prospective, single-arm interventional feasibility study evaluates the Enzeavour Pancreatic Cancer assay in routine health checkups and cancer screening in Japan. Approximately 10,000 asymptomatic adults will be enrolled. Participants with an Enzeavour Score above 0.369 will undergo diagnostic work-up as clinically indicated. The primary outcome is pancreatic cancer detection rate within 12 months after the index blood draw, and the secondary outcome is positive predictive value.

Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer

Our study is a prospective, multicenter, randomized controlled clinical study included patients with stage IV pancreatic ductal adenocarcinoma receiving gemcitabine-based first-line combination therapy according to the 2022 NCCN guidelines and with an estimated survival of \> 3 months. According to reports and previous research results, we plan to include 306 subjects, and the subjects will divide into experimental group and the control group by a ratio of 1:1. All patients in the treatment group will receive QingyiHuaji optimized formula and standard treatment, and patients in the control group will receive placebo combined with standard treatment. Overall survival (OS) is defined as the primary endpoint, and progression-free survival (DFS), quality of life of cancer patients, and relief rate of TCM symptoms are considered as the secondary endpoint to observe the clinical efficacy of Qingyihuaji optimized formula combined with standard chemotherapy for stage IV pancreatic ductal adenocarcinoma. It will provide high-level evidence-based medical basis for the clinical effect of Qingyihuayi optimization prescription on pancreatic cancer with damp-heat accumulation syndrome. The hypothesis of this study is that the combination of Qingyihuaji optimized prescription with standard chemotherapy has the advantage of significantly prolonging the overall survival time, and is feasible and safe for the subjects diagnosed with stage IV pancreatic ductal adenocarcinoma by cytology or histology. The study lasted for 32 months, from 2023 April to December 2025.

Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients

This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time. The study will include adults without diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS. Researchers will study whether participants develop diabetes after surgery and whether this risk changes according to the type of pancreatic resection. Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.

Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus

This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time. The study will include adults with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS. Researchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes. Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.

A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.

Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.

Determining Individualized Cancer Therapy in Pancreatic Cancer

This is a non-therapeutic exploratory observational precision oncology study designed to collect and analyze data that demonstrate the clinical efficacy and tolerability of personalized treatments based on molecular tumor profiling assessments (i.e., matched therapy) in adult pancreatic cancer patients. Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well molecular testing might predicts response to therapy. Patient demographic and outcome parameters to be evaluated include, but are not limited to, tumor response, time to treatment failure, patient survival, and toxicity.

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy

A pancreaticoduodenectomy is performed in patient with pancreatic cancer. The most common and serious complication is leakage between the intestine and the remnant pancreas after this procedure. It occurs in 20-30%. The result is often prolonged hospital and ICU stay, reoperations and deaths (3-5%). To detect a leakage early before the patient becomes seriously ill, thereby initiating treatment is therefore very important. By inserting a thin microdialysis catheter near the anastomosis between pancreas and intestine before closure of the abdominal wall, the investigators will analyze substances such as lactic acid, pyruvate, glycerol, etc. and if these substances may reveal anastomosis leakage at an early stage. Observational studies have shown that if a leakage occurs, glycerol concentration in the microdialysate will rise significant after few hours, and changes in lactic acid and pyruvate values will change as a sign of inflammation. The investigators want to conduct a randomized study comparing patients undergoing pancreaticoduodenectomy and using microdialysis in half of the included population.

A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.

A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus

The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.

A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer

Aberrant miRNA production has been linked to a wide range of human cancers and shown to play important roles in their genesis and growth. These miRNA can be detected in the blood and tumors of patients with cancer. The investigators hypothesize that the detection of certain miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA detection in PC patients will yield prognostic information and help predict the response to treatment.

9-ING-41 in Patients With Advanced Cancers

GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia

This randomized clinical trial compares the hemodynamic effects of general anesthesia versus combined general anesthesia (thoracic epidural) in patients undergoing pancreatoduodenectomy. The primary aim is to assess the incidence of intraoperative hypotension and related adverse events. Secondary outcomes includes vasopressor requirements, transfusion needs, postoperative complications, intensive care unit admission, hospital length of stay, and mortality.

Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases

This Phase II clinical study evaluates the safety and efficacy of a combination therapy for patients with pancreatic cancer that has spread to the liver. Because liver metastases are a major factor in the progression of pancreatic cancer, this research utilizes Hepatic Arterial Infusion Chemotherapy (HAIC) to deliver high-concentration treatment directly into the tumor's blood supply. The multi-step strategy involves first infusing Sodium Bicarbonate to neutralize the acidic tumor microenvironment , followed by the NASOX chemotherapy regimen (Oxaliplatin and Liposomal Irinotecan) and an intra-arterial PD-1 inhibitor to boost immune response. Patients also receive oral S-1 to maintain treatment effect. The primary goal is to determine if this integrated approach can improve Overall Survival for patients compared to historical standard treatments.

Microplastics in Pancreas: Oncologic and Metabolic Impact

Microplastics and nanoplastics (MNPs) are emerging environmental contaminants that have been detected in several human tissues, raising concerns about their potential impact on human health. However, their presence in the human pancreas has not yet been investigated. The aim of this prospective, single-center study is to detect and characterize microplastics in human pancreatic tissue obtained from patients undergoing pancreatic resection for benign or malignant diseases. Microplastics will also be analyzed in peripancreatic adipose tissue and peripheral blood. Advanced imaging techniques, including fluorescence microscopy, confocal microscopy, and Raman spectroscopy, will be used for identification and characterization. Secondary objectives include the evaluation of potential associations between microplastic burden and pancreatic metabolic function, assessed through clinical evaluation and metabolic testing. This proof-of-concept study aims to provide the first evidence of microplastic presence in the human pancreas and explore their potential role in metabolic dysfunction and carcinogenesis.

EUS-guided RFA for Pancreatic Neoplasms

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.

PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor survival outcomes, even when treated with modern chemotherapy and radiation. Patients with borderline resectable PDAC often receive neoadjuvant systemic therapy to improve the likelihood of successful surgical removal of the tumor, but rates of incomplete tumor regression and positive surgical margins remain high. This Phase Ib/II, single-arm study evaluates the safety and feasibility of adding trans-arterial microperfusion (TAMP) delivery of gemcitabine to standard neoadjuvant therapy for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX followed by stereotactic body radiation therapy (SBRT). After completion of chemoradiation, gemcitabine is delivered directly to the tumor through the arterial blood supply using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy drug for pancreatic cancer, and the study is evaluating a novel method of delivering the drug rather than a new medication. The primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine in this treatment setting. Secondary objectives include evaluation of surgical margin status and pathologic tumor regression following surgical resection. Exploratory analyses will examine relapse-free survival. Results from this study will help determine whether this locoregional chemotherapy approach can be safely integrated into neoadjuvant treatment strategies for patients with borderline resectable PDAC.

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts

The aims of this study are to determine the natural history of pancreatic cysts and to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.

Operative Risk After Pancreatic Surgery in Patients With End Stage Renal Disease

End-stage renal disease (ESRD) patients often present risk factors for many surgical complications. The severity of renal failure and whether the patient is receiving renal replacement therapy are also related to the difficulty of pancreatic and other major surgeries, causing many ESRD patients to hesitate when choosing surgery. Therefore, this project aims to retrospectively collect basic data, preoperative and postoperative blood tests (blood cell counts, biochemistry, tumor markers, glucose-related, lipid-related), and preoperative and postoperative imaging examinations (CT, MRI, Ultrasound, PET scan, Endoscopy, etc.) of ESRD patients who underwent pancreatic surgery at our hospital.the investigators aim to compare whether surgical methods, severity of renal failure, use of renal replacement therapy, and lesion margin clearance rates affect the occurrence of surgical complications, length of hospital stay, length of ICU stay, re-operation rates or severe complications, medical costs, and related quality of life. This analysis is intended to understand and analyze the surgical prognosis, care priorities, common complications, and the management and outcomes of our team for ESRD patients undergoing pancreatic surgery, with the expectation of providing more diverse and specific treatment recommendations for these patients in the future.