Queen Creek

Researchers are evaluating the efficacy and safety of UGN-104, a new formulation of UGN-101 (known as JELMYTO), for treating patients with low-grade upper tract urothelial cancer (LG-UTUC). This Phase 3, single-arm, multicenter study focuses on patients with LG-UTUC in the upper urinary tract. The study aims to measure the complete response rate about 3 months after the first treatment instillation. Participants will receive UGN-104 once weekly for 6 weeks, totaling 6 doses. UGN-104 is a drug combining mitomycin with a sterile hydrogel that changes from liquid to gel when warmed, helping deliver the medication directly to the upper urinary tract. Patients who achieve a complete response with no detectable disease at the primary disease evaluation visit may enter a follow-up period, where they can receive monthly maintenance doses of UGN-104 for up to 11 months. Patients will be monitored every 3 months during follow-up for up to 12 months or until disease progression, recurrence, or death. Throughout the study, patients undergo evaluations including urine cytology, visual inspections with ureteroscopy, and biopsies if needed. Response determination is centrally reviewed using laboratory and histopathology assessments. Safety and disease status will be closely monitored during treatment and follow-up visits to assess treatment effect and patient well-being.

Researchers are evaluating the efficacy and safety of an intravesical injection called T3011 in adults with high-risk non-muscle invasive bladder cancer (NMIBC) who do not respond to BCG treatment or who have intermediate to high-risk NMIBC that does not respond to chemotherapy after BCG exposure. This Phase II study includes participants with different subtypes of NMIBC, including carcinoma in situ and papillary tumors, and aims to explore treatment options for this challenging condition. The study involves four cohorts based on the specific characteristics of the bladder cancer and prior treatments. Participants receive T3011 injections directly into the bladder at a dose of 1x10^10 PFU once weekly for six weeks as an induction course. Those with residual disease at three months may receive a reinduction course, while participants achieving complete response or no recurrence enter a maintenance phase with T3011 administered every three weeks. Disease status is monitored regularly with cystoscopy, urine cytology, biopsies, and imaging as needed. Participants will undergo assessments every three months during the treatment period to evaluate response and detect any recurrence. The study measures complete response rates, recurrence-free survival, and the occurrence of treatment-related adverse events over two years. Safety monitoring includes tracking side effects that might lead to treatment changes or discontinuation. The total participation duration depends on disease status and treatment response, with ongoing evaluations to ensure patient safety and treatment effectiveness.

Researchers are evaluating the use of an AI-based health solution called CHAPERONE to help people with chronic conditions affecting the heart, kidneys, and metabolism. The study focuses on how the AI chatbot, Copilot, a large language model, and a vital sign monitoring device can work together to reduce the burden of Cardiovascular Kidney and Metabolic (CKM) diseases by using algorithms based on biomarkers and diagnostic data collected through remote sensor technology. The study highlights the significant impact of diabetes, heart disease, and kidney disease, which often occur together and increase risks of serious complications, while emphasizing the importance of early detection and lifestyle changes to slow disease progression. The study involves two main interventions: the CHAPERONE AI treatment strategy, which uses machine learning and AI tools to help manage CKM conditions and aims to reduce kidney failure, heart failure, heart attacks, diabetes complications, hospitalizations, and death; and the CKMiq AI device intervention, which targets reducing hospital readmissions from cardiovascular causes and improving patient-reported well-being through recognized biomarker assessments and risk scoring. Additional measures include assessing quality of life and health status via surveys such as the LIFE ESSENTIAL-8 Score and the SF-12 survey. Participants will be monitored over 30, 90, and 180 days to evaluate treatment effects on health outcomes including kidney and heart complications, hospitalizations, and mortality. Assessments will include biomarker analysis, patient self-assessments, and quality of life questionnaires. The study aims to empower patients through coordinated care and technology to improve long-term health management and reduce disease complications. Monitoring will be ongoing during the study periods to track the impact of the AI-driven interventions on CKM disease progression.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of TARA-002, given directly into the bladder, in adults aged 18 years or older with high-grade non-muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without Ta/T1. This Phase 2, open-label study focuses on participants who have active disease confirmed at their last tumor evaluation, enrolling them into two groups based on their prior exposure to BCG treatment. All participants receive six weekly doses of TARA-002 at a dose established in a previous Phase 1 study during the first treatment period. Those eligible for reinduction receive six more weekly doses in the second treatment period. Participants who achieve a complete response after the first treatment receive three additional weekly doses as maintenance during the second period. A third treatment period provides all eligible participants with three weekly doses at months 6, 9, 12, 15, and 18. Following treatment, participants enter a follow-up phase lasting from month 21 to month 60. During the study, researchers assess the occurrence of a high-grade complete response at any time from month 3 to month 60, including subgroup analyses for certain cohorts. Participants undergo pathology reviews to confirm response. The study monitors safety and efficacy throughout treatment and long-term follow-up, with evaluations designed to capture the duration and quality of the treatment response over several years.