Weinan

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 investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.

Researchers are evaluating the effects of different amlodipine-based treatments on the risk of first ischemic stroke in Chinese adults aged 45 to 74 years with hypertension and the MTHFR 677 TT genotype. This large, multi-center, randomized, double-blind, triple-dummy controlled trial aims to compare amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate over a 5-year period. The study focuses on preventing ischemic stroke as the primary outcome. Participants first undergo a screening period to confirm eligibility through interviews, clinical evaluations, and lab tests. Those who qualify enter a 2 to 4 week run-in phase with daily amlodipine to check treatment tolerance and compliance. Eligible participants are then randomly assigned to one of three daily oral treatment groups amlodipine alone, amlodipine folic acid, or amlodipine folic acid plus 5-MTHF. Additional antihypertensive medications may be added as needed to control blood pressure. Participants are followed every 3 months for drug distribution and monitoring. Throughout the study, participants will have regular clinical visits, interviews, and biological sample collections to monitor health and treatment effects. Researchers will track the incidence of first ischemic stroke and other cardiovascular and kidney outcomes over five years. Safety and treatment adherence are carefully observed, with two planned interim analyses during the trial. Total participation spans from initial screening through five years of treatment and follow-up.

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 effectiveness and safety of Weifuchun tablet in treating gastric intestinal metaplasia in adults who do not have Helicobacter pylori infection. The study aims to determine whether Weifuchun tablet can promote the regression of this condition compared to folic acid, following guidelines from the Chinese consensus on managing gastric precancerous conditions. It is a Phase 4, open-label, randomized controlled trial involving adults aged 18 to 75 years old. Participants are randomly assigned to one of two groups one group takes Weifuchun tablets at a dose of 1400 mg three times daily, while the other group takes folic acid tablets at 5 mg three times daily. Both treatments are taken orally every day for 6 months. Participants visit the clinic every 4 weeks for checkups, symptom evaluation, and to receive their medication supply. During the study, participants undergo regular assessments including upper gastrointestinal endoscopy and histopathological examinations to monitor the regression or progression of gastric intestinal metaplasia and gastric atrophy based on OLGIM and OLGA stages. Researchers measure outcomes from enrollment to the end of the 6-month treatment. Safety and side effects are also monitored throughout the trial, which lasts for the full 6 months of treatment.

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.

Liver failure is a serious condition caused by various factors such as viral infections, alcohol use, drug effects, and blood flow problems, often accompanied by damage to other organs and a high risk of death. This research aims to build a real-world database of hospital patients with liver failure across multiple centers in China. The study will investigate clinical features, infection patterns, the role of muscle loss on patient outcomes, and ways to improve treatments like antiviral therapy and artificial liver support. The findings will support future studies addressing complications and early warning signs in critically ill liver failure patients. The study groups include patients with acute liver failure ALF, subacute liver failure SALF, and acute-on-chronic liver failure ACLF, defined by timing and liver disease history. Data will be collected using an electronic system from hospitalized patients fitting these categories, without administering experimental treatments since this is an observational registry. Participants will undergo clinical data collection during their hospital stay, focusing on symptoms, liver enzyme levels, bleeding risk, infections, and muscle condition. Researchers will measure survival rates at 28 and 90 days and track disease progression up to 48 weeks after discharge. This ongoing monitoring aims to better understand liver failure outcomes and improve care strategies over time.

Researchers are evaluating the usefulness of serial PSMA PET scans to monitor therapy in men newly diagnosed with clinically significant prostate cancer, defined by a Gleason score of 7 or higher. This prospective, multicenter, observational study aims to improve treatment response assessment, which currently relies on PSA changes and conventional imaging that may lack early sensitivity. The study includes patients scheduled for curative-intent or systemic therapy such as radiotherapy, androgen deprivation therapy ADT, chemotherapy, or combinations thereof. Participants undergo a baseline PSMA PETCT scan before starting any treatment. A follow-up PSMA PETCT scan is performed either when PSA levels indicate recurrence or within 12 to 24 months after completing treatment if no recurrence occurs. The same radiotracer and scanner are used for consistency. Researchers will analyze changes in maximum standardized uptake value SUVmax and the number of PSMA-avid lesions, correlating these with treatment response categories defined by PSA kinetics, conventional imaging, and clinical outcomes. During the study, patients receive standard treatments determined by their physicians. Researchers collect imaging data centrally and analyze it with standardized software, including independent lesion counts by two nuclear medicine physicians. Outcome measures include changes in SUVmax and lesion count, treatment strategy changes, agreement between PSMA PET and PSA responses, and associations with progression-free survival and time to castration resistance. The study follows participants for up to two years, assessing safety, adherence to follow-up imaging, and clinical outcomes.