Yan An Shi

Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA PET scans compared to enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to see if 68Ga-PSMA PET can influence treatment decisions for these patients. This prospective, multicenter trial is sponsored by Xijing Hospital and focuses on improving diagnosis and management for renal cancer with metastases. Participants in the study will receive both a 68Ga-PSMA PET scan and an enhanced CT scan simultaneously to compare their abilities to detect cancer spread. This diagnostic approach helps assess the additional value that 68Ga-PSMA PET may provide over standard CT imaging. The study does not involve any masking or placebo groups and includes only patients who meet specific clinical and imaging criteria. During the study, patients will undergo imaging within six weeks after diagnosis, and researchers will track how the 68Ga-PSMA PET results affect treatment choices. The primary measurement is the additional diagnostic value of the PSMA PET compared to CT over two years. Secondary outcomes include how often the PET scan changes treatment decisions. The study monitors patient safety and adherence, with a planned follow-up period to evaluate outcomes until December 2027.

Researchers are studying the prognostic value of prostate-specific membrane antigen PSMA positron emission tomography PET scans in men newly diagnosed with prostate cancer who have not yet received treatment. The goal is to understand how initial PSMA PET imaging can predict progression-free survival and to develop a prognostic tool called the PSMA-VISION score. This study addresses a gap by focusing exclusively on untreated patients at initial staging to improve risk assessment accuracy. This observational study collects data from patients who have undergone PSMA PET as their first staging method before any treatment. The study will analyze baseline PSMA PET parameters, such as SUVmax, lesion count, and metastatic stage, along with clinical variables to create and validate a prognostic model. It also compares this new model with existing tools like NCCN risk categories and the PPP nomogram, aiming to enhance prediction of progression-free and overall survival. Participants will be followed for at least two years to assess progression-free survival and up to ten years for overall survival. Researchers will gather clinical data, imaging results, and pathology reports at regular intervals to evaluate disease progression and survival outcomes. Data will be securely stored and analyzed using statistical models to develop accurate risk stratification tools for prostate cancer management.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

This research aims to observe the effects of different antithrombotic drugs on patients over 40 years old who have had an ischemic stroke and also have cerebral microbleeds. Cerebral microbleeds are small brain vessel injuries causing deposits of blood breakdown products, which can increase the risk of brain bleeding. The study also uses proteomic methods to find blood markers that might predict how these patients will recover. Participants will be observed for one year after their stroke while using various antithrombotic drugs, which are commonly prescribed to prevent further strokes but may raise the risk of brain bleeding in these patients. The study involves tracking changes in cerebral microbleeds and stroke recurrence, along with analyzing blood samples to identify proteins linked to patient outcomes. During the one-year study period, participants will have their brain microbleeds monitored and stroke recurrence rates recorded. Blood tests will be done to explore protein markers that could help predict prognosis. The main outcome measured is the increase in cerebral microbleeds one year after stroke onset, with secondary outcomes including stroke recurrence and incidence of brain hemorrhage. Safety and progress will be closely followed throughout the study.

Researchers are conducting a nationwide, multicenter observational study to establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. The study will include patients with respiratory syndrome from various hospital settings across seven regions in China. It aims to monitor pathogen trends, support risk assessment, and provide evidence for prevention and control strategies over several years. Participants diagnosed with respiratory syndrome will have clinical data collected every two weeks, including demographics, symptoms, diagnoses, lab tests, medications, oxygen therapy, hospital stays, ICU admissions, and outcomes. For those meeting specific diagnostic criteria, respiratory and other biospecimens will undergo a range of tests including routine pathogen tests, multiplex PCR, targeted and metagenomic sequencing, antibody and cytokine testing, and exploratory multi-omics analyses. During the study, data and specimens will be collected routinely from participants receiving clinical care. Researchers will generate national and regional surveillance reports to support early warnings and prevention efforts. The main outcomes measured include detection rates and types of respiratory pathogens and immune responses after infection or vaccination, tracked over three years. Participation involves regular data reporting through secure channels without additional treatment interventions.

Researchers are evaluating whether delayed PSMA PET imaging improves the detection of clinically significant prostate cancer compared to standard imaging in men suspected of having newly diagnosed prostate cancer. This prospective, multicenter study focuses on patients who have not yet undergone treatment and aims to fill the gap in evidence about the benefits of delayed imaging timing. The study compares diagnostic accuracy using imaging results and prostate biopsy findings as the standard. All participants undergo two sets of PSMA PETCT scans a standard whole-body scan about 60 minutes after tracer injection and a delayed pelvic-focused scan 2 to 3 hours post-injection. The delayed images use the previously acquired CT data for correction. Each patient acts as their own control, allowing for direct comparison of the two imaging approaches. Biopsy results serve as the reference to confirm the presence and severity of cancer. During the study, patients will have imaging scans followed by prostate biopsies to confirm diagnosis. Researchers will analyze the imaging results to compare their accuracy in detecting clinically significant prostate cancer. Outcomes include measures like the area under the curve AUC for imaging accuracy, biopsy avoidance potential, changes in clinical management, and subgroup analyses by PSA levels. An independent monitor oversees data quality and safety throughout the study, which will continue until 2028.

Researchers are evaluating the effects and safety of fenofibrate in patients with compensated cirrhosis due to primary biliary cholangitis PBC who have not responded adequately to ursodeoxycholic acid UDCA. This multi-center, randomized, placebo-controlled study aims to assess whether adding fenofibrate to UDCA improves biochemical markers over 12 months. The study is conducted by Xijing Hospital of Digestive Diseases and includes participants aged 18 to 75 years with confirmed PBC and compensated cirrhosis. Participants will be randomly assigned to receive either fenofibrate 200 mg daily or a placebo, both combined with UDCA at 13-15 mgkg per day for 12 months. This quadruple-masked trial compares these two groups in parallel to evaluate fenofibrates biochemical response and safety profile. The treatment period lasts for one year with daily medication intake. Throughout the study, participants will have regular assessments including blood tests to measure biochemical response at multiple time points up to 48 weeks. Researchers will also monitor symptoms like itching and fatigue, track any biological or clinical adverse events, and evaluate survival without liver transplantation or hepatic impairment. Safety and treatment effects will be closely observed across the full duration of the trial.

Researchers are investigating how changes in multigene methylation levels in the blood relate to treatment responses in people with esophageal cancer. The study aims to understand if these methylation changes correspond with objective response rates seen in imaging scans and serum tumor markers. Secondary goals include examining how methylation patterns relate to progression-free survival, comparing methylation to standard biomarkers, and exploring if methylation can guide treatment adjustments. Participants are grouped based on their treatment approach surgery alone, surgery after neoadjuvant therapy, active surveillance after neoadjuvant therapy, or definitive chemoradiotherapy with or without immunotherapy. All participants undergo regular blood tests for multigene methylation during follow-up, with specific timing depending on their treatment group. The study involves multiple assessments through pre-scheduled timepoints extending up to five years post-treatment. Throughout the study, participants will have blood samples taken at various intervals up to five years to measure methylation levels. Additional evaluations include tumor marker tests, imaging scans such as contrast-enhanced CT, PETCT, ultrasound, X-rays, MRI, and endoscopies following a set schedule based on the treatment group. Researchers will monitor these results to evaluate treatment response and disease progression over time, ensuring comprehensive long-term follow-up and safety monitoring.

Researchers are investigating a plasma exosome RNA signature to diagnose clinically significant prostate cancer. This observational study aims to evaluate the diagnostic accuracy of a plasma exo-RNA panel alone in identifying this condition. Additionally, the study compares this RNA panels performance with other imaging methods or blood tests to assess its effectiveness at the time of prostate biopsy. Participants suspected of having prostate cancer based on clinical symptoms, digital rectal exam, ultrasound, or MRI will be observed. The study involves collecting blood samples to analyze the plasma exo-RNA panel. There is one study cohort receiving diagnosis from the serum RNA combination without additional intervention. The study does not include drug or treatment administration. During the study, participants will undergo prostate biopsy and clinical assessments to confirm diagnosis. Researchers will measure the diagnostic efficacy of the plasma exo-RNA panel and compare it with other diagnostic tools. The study involves monitoring at the time of prostate biopsy, with no further treatment or intervention specified. Participation duration varies depending on individual diagnostic procedures and follow-up needs.

Researchers are investigating a new way to predict bone metastasis in prostate cancer using a blood test that analyzes plasma exosomal RNA. This test aims to serve as a non-invasive rule-out method compared to the current standard imaging, PSMA PET, which is expensive and involves radiation. The study is divided into four phases, including discovery, model development, internal validation, and external validation, to develop and test this RNA-based signatures accuracy and usefulness. The study includes a single group of 1000 men with suspected or confirmed prostate cancer who have not yet received treatment. Blood samples are taken before any treatment or biopsy to analyze exosomal RNA. The four phases include identifying RNA candidates through sequencing, developing a predictive model using digital PCR and machine learning, validating the model in a natural disease group, and externally validating it in a multi-center group. Bone metastasis is determined by PSMA PET scans. Participants will provide blood samples and may undergo prostate biopsy if needed. Researchers will assess the RNA tests performance by measuring sensitivity, specificity, predictive values, and correlation with imaging and clinical markers such as PSA levels and MRI findings. The study will also explore biological mechanisms and subgroup differences. Data confidentiality is maintained, and the study plans to run until 2027.