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Researchers are evaluating the adaptation and implementation of an innovative clinical decision support CDS tool called ePNa, originally validated in emergency departments, for use in urgent care clinics to improve pneumonia diagnosis and treatment. This study aims to combine ePNa with Stanfords CheXED artificial intelligence model to classify chest images quickly and accurately. The goal is to enhance pneumonia care in ambulatory settings where high patient volumes may benefit from updated and efficient diagnostic tools, especially as COVID-19 evolves. The study involves adapting ePNa for use in urgent care clinics by modifying it to work with the more limited patient data available in these settings and incorporating a chest imaging prompt. The combined ePNa-CheXED tool will be piloted among super user clinicians during clinic shifts. One of two clusters of urgent care clinics will receive the adapted tool, while the other will serve as usual care control. Additionally, a physician survey will assess clinicians experiences with ePNa-CheXED six months after implementation. Participants will be patients aged 12 and older diagnosed with pneumonia, confirmed by radiographic imaging. Physicians and advanced practice clinicians in selected urgent care clinics will also participate by completing surveys. The study will monitor outcomes including the accuracy of pneumonia diagnosis, changes in transfer rates to emergency departments, unplanned subsequent ED visits or hospitalizations, and overall healthcare resource use. The study will continue for up to three years, with ongoing evaluation of ePNa use and impact in the urgent care clinical environment.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are studying how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years with newly diagnosed B acute lymphoblastic leukemia that is CD22 positive. This phase III trial investigates the side effects and effectiveness of this combination compared to chemotherapy alone, aiming to improve event-free survival and other outcomes. The study also explores genetic and molecular markers to better understand treatment response and risks. Participants receive a pediatric-inspired chemotherapy regimen called CALGB 10403, which includes multiple courses of treatment remission induction, remission consolidation, interim maintenance, delayed intensification, and maintenance therapy. Some patients also receive inotuzumab ozogamicin intravenously on specific days, followed by blinatumomab if minimal residual disease is detected. Treatment cycles repeat according to response and tolerance, with additional therapies like rituximab and radiation as needed. Imaging and laboratory tests are done throughout. During the trial, participants undergo regular assessments including bone marrow biopsies, blood tests, and imaging such as echocardiography or multigated acquisition scans. Researchers measure outcomes like event-free survival, disease-free survival, overall survival, response rates, and treatment side effects for up to 10 years. After treatment, patients are followed closely every few months for up to 10 years to monitor long-term effects and disease status.

Researchers are evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating how well radiation therapy works compared with observation in patients who have a newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiation therapy after complete tumor removal and also studies overall survival, disease-specific survival, side effects, neurocognitive function, patient-reported outcomes, and biomarker correlations. Participants are randomly assigned to one of two groups. One group undergoes observation with regular MRI scans and blood collection throughout the study. The other group receives intensity-modulated radiation therapy IMRT or proton beam radiation therapy five days a week for about 6.5 to 7 weeks, totaling 33 treatment sessions, unless disease progression or unacceptable side effects occur. Both groups continue to have MRI scans and blood tests during the study. Participants are followed for up to 10 years after treatment or observation, with visits scheduled at 3, 6, and 12 months, then every 6 months for years 2 and 3, and yearly thereafter. The study measures time without disease progression as the main outcome, along with survival rates, adverse events, cognitive function changes, and adherence to treatment protocols. Tissue and blood samples are also collected for ongoing research.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are investigating how well standard systemic therapy, with or without additional definitive treatment such as prostate removal surgery or radiation therapy, works in treating men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and progression outcomes between patients receiving systemic therapy alone and those receiving systemic therapy plus definitive treatment of the primary tumor. The study also examines quality of life factors, including urinary function, pain, and physical functioning. Participants first receive one of six acceptable forms of standard systemic therapy for 22 to 28 weeks, which may include hormonal therapies, oral medications, injections, or chemotherapy drugs like docetaxel. After this induction period, participants are randomly assigned to continue standard systemic therapy alone or to receive systemic therapy plus prostatectomy or radiation therapy within a specific timeframe. Following treatment, participants are monitored and followed up for up to eight years. During the study, participants undergo various assessments including physical exams, laboratory tests for prostate-specific antigen PSA and testosterone levels, and imaging scans to monitor disease progression. Patient-reported outcomes related to urinary symptoms, pain, and quality of life are collected at multiple time points up to three years. The main outcome measured is overall survival over an eight-year period. Researchers also bank tissue and blood samples for future studies and observe safety and disease progression throughout the follow-up period.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.