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Researchers are evaluating a clinical decision support (CDS) tool called ePNa, originally designed for emergency departments, to improve pneumonia diagnosis and treatment in urgent care clinics in Utah. This study focuses on adapting ePNa for use in urgent care centers (UCCs), where pneumonia patients are frequently seen, and combining it with Stanford's CheXED artificial intelligence model to enhance chest image analysis. The goal is to implement and test this adapted tool to support clinicians in making accurate and timely pneumonia care decisions, especially as diagnostic and treatment methods evolve during the COVID-19 pandemic. The study involves adapting ePNa to fit the data limitations and workflow of urgent care clinics, incorporating AI-based chest image classification that provides results in less than one second. The adapted tool will be piloted with selected "super user" clinicians and then deployed to one of two randomly chosen UCC clusters, while the other cluster continues usual care. The implementation process will follow the CFIR framework for best practices in integrating new clinical tools, including identifying barriers and facilitators through focus groups, interviews, and workflow observation. Participants include pneumonia patients aged 12 years and older with specific diagnostic codes, and clinicians working in the selected urgent care clinics. The study will collect data on pneumonia diagnosis accuracy, patient transfers to emergency departments, and safety outcomes like unplanned hospital visits and mortality within 30 days. Physician surveys will assess user experience with ePNa. The study is planned to last up to three years, with ongoing monitoring of how ePNa impacts urgent care clinical environments.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years who have newly diagnosed B acute lymphoblastic leukemia (ALL). This Phase III trial aims to confirm the safety and effectiveness of adding inotuzumab ozogamicin, a monoclonal antibody that targets cancer cells, to a pediatric-inspired chemotherapy regimen called CALGB 10403. The study also explores the impact of this combination on survival, minimal residual disease, genetic factors, treatment side effects, and medication adherence. Participants begin with remission induction therapy that includes oral allopurinol, intravenous and intrathecal chemotherapy drugs such as daunorubicin, vincristine, dexamethasone, pegylated L-asparaginase, and methotrexate, along with bone marrow tests. Those who respond to induction are randomized to one of two groups: one receives standard chemotherapy courses including consolidation, maintenance, and intensification phases, while the other receives inotuzumab ozogamicin infusions in addition to the same chemotherapy regimen. Treatments are given by mouth, intravenous, subcutaneous, or intrathecal routes on specific days over several courses lasting up to three years for maintenance therapy. Throughout the study, participants undergo regular bone marrow biopsies, blood tests, and biomarker analyses to monitor disease status and treatment effects. Researchers assess event-free survival, disease-free survival, overall survival, treatment toxicity, genetic markers, and medication adherence using electronic monitoring. After treatment ends, patients are followed monthly for the first year, then less frequently up to ten years to track long-term outcomes and safety.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating how well radiation therapy works compared to observation in patients with newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiotherapy after gross total resection of the tumor, while also assessing overall survival, disease-specific survival, side effects, cognitive function, patient-reported outcomes, and biomarker validation. Participants are randomly placed into one of two groups: the first group undergoes observation with regular MRI scans and blood collections, while the second group receives intensity-modulated radiation therapy or proton beam radiation therapy five days a week for about 6.5 to 7 weeks. Treatment continues up to a total of 33 radiation sessions unless the disease progresses or unacceptable side effects occur. Both groups are monitored with imaging and blood samples throughout the study. After treatment, participants are followed up at 3, 6, and 12 months, then every six months for the second and third years, and yearly up to 10 years. Researchers measure progression-free survival from randomization until disease progression or death. The study also collects tissue and specimen samples for future research and monitors patients for side effects and quality of life over the long term.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works for patients with hormone receptor positive, HER2 negative metastatic breast cancer. The study compares STMDDM with the usual care approach to see if overall survival is not worse using STMDDM. The trial also looks at healthcare costs, patient anxiety, quality of life, and preferences related to disease monitoring. Patients are randomly assigned to one of two groups. One group receives usual care with imaging at least every 12 weeks and other monitoring at the doctor's discretion for up to 312 weeks if the disease does not progress. The other group has their serum tumor markers checked every 4 to 8 weeks, with imaging only if markers are elevated, also for up to 312 weeks without progression. Additional assessments include quality-of-life and anxiety questionnaires. Throughout the study, participants undergo regular evaluations including imaging, blood tests for tumor markers, and patient-reported outcome questionnaires. Researchers track overall survival up to 312 weeks after randomization, along with healthcare costs and patient experiences. Participants must provide informed consent and are monitored for safety during the study period.

Researchers are investigating how well standard systemic therapy alone or combined with definitive treatment (prostate removal surgery or radiation therapy) works in men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and other outcomes such as progression-free survival and quality of life between these treatment approaches. The study also explores differences in urinary function, pain, and physical functioning reported by patients over time. Participants begin with an induction period of 22 to 28 weeks receiving one of six forms of standard systemic therapy, which may include hormonal treatments, chemotherapy with docetaxel, or other approved medications. After this period, they are randomly assigned to either continue standard systemic therapy alone or receive standard systemic therapy plus definitive treatment of the primary tumor through prostatectomy within 8 weeks or radiation therapy within 4 weeks. The treatments are given according to accepted schedules, such as subcutaneous or intramuscular injections, oral medications, or intravenous infusions. During the study, participants undergo various assessments including physical exams, lab tests for prostate-specific antigen and testosterone levels, imaging scans, and patient-reported quality of life questionnaires. Researchers follow participants for up to 8 years to measure overall survival and monitor disease progression, symptoms, and side effects. Tissue and blood samples may be collected for future research. The study also tracks urinary and physical function changes and pain levels at multiple time points after starting therapy.