Stafford Township

Researchers are evaluating WSD0922-FU in a Phase II, open-label, multicenter, single-arm study for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after first-line treatment with Osimertinib and whose tumors have a specific mutation called C797S in the EGFR gene. This study aims to assess the safety and effectiveness of WSD0922-FU, which is designed to target both the original EGFR mutations and the resistance mutation that can develop after Osimertinib treatment. The treatment involves oral WSD0922-FU tablets given in 21-day cycles at two possible dose levels (Dose level A or B). Patients will receive this investigational drug continuously during the study period. The study focuses on patients with advanced NSCLC, including those with or without brain metastasis, who have shown disease progression on prior Osimertinib therapy. Participants will undergo regular assessments every 8 weeks for up to one year to measure their tumor response rate. Study visits will include evaluations of disease status through imaging and clinical examinations, safety monitoring, and other laboratory tests as needed. The study requires patients to have a good performance status and a life expectancy of at least 12 weeks, ensuring they can participate in the full treatment and assessment schedule.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are evaluating two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

Researchers are conducting a pilot trial called the LEAD Pilot Study to address lung cancer screening disparities by targeting eligible patients in the Emergency Department using an Electronic Health Record-embedded Social Determinants of Health screening tool. The study aims to evaluate the reach, or the number and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake, and to assess the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care. The trial uses quantitative methods including a randomized controlled trial and EHR data analysis to explore factors influencing lung screening uptake such as health literacy, mistrust, stigma, fatalism, and knowledge about lung screening.

Researchers are evaluating the use of Tamsulosin to reduce the high rate of postoperative urinary retention (POUR) in men aged 55 and older undergoing thoracic oncological surgery for suspected or confirmed cancer. This early phase 1 feasibility study aims to see if Tamsulosin can help patients resume normal urinary function after surgery and lower complications such as urinary tract infections and extended hospital stays. The condition affects mainly older men with enlarged prostates even after adjusting for other risk factors. Participants will take Tamsulosin 0.4 mg once daily after a meal for seven days before their scheduled surgery. After surgery, bladder ultrasounds will be performed about six hours post-operation to measure urine volume and check for retention. Depending on the ultrasound results and the patient's ability to urinate naturally, the study will monitor and manage bladder function using intermittent catheterization if necessary, with further intervention considered if large urine volumes remain for more than 24 hours. During the study, researchers will track spontaneous urination within 6 to 8 hours after surgery, timing and volume of urine, residual urine measured within 24 hours, and any need for interventions due to inability to urinate. Standard bladder management will be provided as needed, with measurements taken using BladderScanner ultrasound. The study focuses on safety and efficacy of preventing POUR and requires monitoring for up to 24 hours post-surgery to assess urinary function recovery.

Researchers are studying the use of targeted genomic analysis of blood and tissue samples from patients with cancer, focusing especially on rare cancers with poor prognosis or those lacking effective treatments. This research aims to identify specific genetic changes that contribute to cancer development and to improve diagnosis and treatment options by analyzing the entire genetic makeup of cancer cells. The study collects detailed genomic data to support future research and clinical care. Participants provide blood and tumor tissue samples, which undergo next-generation sequencing to detect genetic mutations. These mutations are then reviewed to find those with available targeted therapies, and this information is shared with treating doctors to guide patient care or referrals to other studies. Previously collected tissue samples may also be analyzed, and blood samples are collected to examine circulating tumor DNA and cells. After the initial sample collection and analysis, patients are followed up every three months for two years, then every six months for up to fifteen years. During this time, researchers monitor the frequency of specific mutations and combinations in related genes, as well as the rate of actionable mutations in rare or poor prognosis cancers. The study also collects clinical outcomes, tumor genome data, and tumor tissue for further research and model development.

Researchers are evaluating patients who have had surgical removal of bladder, kidney, ureter, or urethra due to muscle-invasive urothelial cancer. This phase II/III trial studies whether a blood test measuring circulating tumor DNA (ctDNA) can identify patients at higher risk of cancer returning, and whether immunotherapy treatments including nivolumab and relatlimab can help prevent recurrence and prolong survival. The study aims to determine if ctDNA levels after surgery can guide the need for additional immunotherapy treatment and compare outcomes between different treatment approaches. Patients are assigned to one of two groups based on their ctDNA test results after surgery. Those with positive ctDNA (Cohort A) are randomly assigned to receive either nivolumab alone or nivolumab combined with relatlimab via intravenous infusion every 28 days for up to 12 cycles. Patients with negative ctDNA (Cohort B) are randomly assigned to receive either immediate nivolumab treatment or ctDNA surveillance with treatment starting only if ctDNA becomes positive. Throughout the study, participants undergo tissue and blood sample collections, imaging scans such as CT or MRI, and may have cystoscopy procedures. Participants are closely monitored during treatment and after completing therapy with follow-up visits scheduled at multiple time points up to 248 weeks. Researchers assess the clearance of ctDNA, overall survival, disease-free survival, and quality of life using questionnaires. Safety is also evaluated, and the study explores associations between ctDNA changes and patient outcomes. This comprehensive monitoring helps to understand the benefits and risks of the immunotherapy treatments and the role of ctDNA in guiding therapy for urothelial cancer patients.