Salisbury

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

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 investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of death worldwide, causing significant health and economic burdens. This research focuses on evaluating the WearME system's ability to monitor COPD severity and respiratory function by comparing its measurements with standard clinical tools like spirometry and capnography. The study aims to provide innovative technology access to underserved patients in low-income, rural, and ethnically diverse communities in the Mid-Atlantic region. The study will assess the WearME-Pro system's accuracy in measuring forced expiratory volume in one second (FEV1), forced vital capacity (FVC), respiratory rate, heart rate, inspiratory to expiratory ratio (I:E ratio), spinal range of motion, and activity levels. Up to 128 participants with COPD will wear the WearME device during a 145-minute data collection session. The study includes participants stratified into four groups based on COPD severity using the GOLD standard. The WearME-Basic system will also be evaluated simultaneously using the same hardware. Participants will undergo assessments during the data collection period, including spirometry and other standard medical device measurements for comparison. Researchers will measure how closely the WearME system's readings agree with gold standard devices, focusing primarily on FEV1 and FVC values. Safety and accuracy monitoring will continue within six months of study start. This observational study involves both clinical evaluations and device data collection to better understand the WearME system's potential for continuous and remote COPD monitoring.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Amyotrophic Lateral Sclerosis (ALS) is a serious neurodegenerative disease where motor neurons in the brain and spinal cord gradually die, leading to severe physical impairment. Because there is currently no cure for ALS, this study focuses on understanding how different factors affect the quality of life for people living with this disease. The research aims to explore the connection between patients' physical functioning and their reported quality of life, while also considering how the stage of the disease may influence this relationship. Participants in this observational study will be patients diagnosed with ALS who receive care at the TidalHealth Peninsula Regional Multidisciplinary ALS Clinic. They will complete the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) to report their quality of life every other clinic visit over a two-year period. Alongside this, their physical functioning will be assessed using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) at every standard clinic visit, which typically occur regularly as part of their ongoing care. During the study, participants will be assessed through these questionnaires at routine clinic visits up to two years. Researchers will measure the correlation between physical function and quality of life, and how disease stage affects this relationship. This includes monitoring scores from both ALSAQ-40 and ALSFRS-R over time to better understand patient experiences. The study also tracks safety and adherence through the standard-of-care visits without additional interventions.

Chronic low back pain (LBP) is a leading cause of disability worldwide and a major factor in healthcare costs and opioid use in the United States. Physical therapy is an effective and cost-efficient treatment to improve pain and function in chronic LBP patients, but many patients, especially those in rural areas, face barriers such as limited provider availability, transportation challenges, and missed work time. This trial investigates whether a risk-informed telerehabilitation approach can improve access and outcomes for patients with chronic LBP in rural communities compared to standard web-based education. Participants will be randomly assigned to either a standardized education group, which provides online access to evidence-based information about chronic LBP and self-management strategies, or a risk-informed telerehabilitation group. The telerehabilitation treatment is tailored based on patients’ risk levels and includes video physical therapy visits ranging from standard to psychologically informed approaches. This trial will enroll 434 patients from rural primary care clinics and deliver interventions over 8 weeks. Throughout the study, participants will be monitored for changes in LBP-related disability using the Oswestry Disability Index and opioid use at 12 weeks after treatment begins. Researchers will also gather feedback through surveys and interviews to understand the quality and impact of telerehabilitation on access barriers. The goal is to improve physical function, quality of life, and reduce opioid use in patients with chronic LBP living in underserved rural regions.

Researchers are evaluating inclisiran, a subcutaneous injection given twice yearly, to see if it can prevent major cardiovascular and limb events in patients undergoing percutaneous coronary or peripheral arterial revascularization. This Phase 4, randomized, double-blind study includes patients with symptomatic coronary artery disease or peripheral artery disease who have recently had successful revascularization procedures. The trial aims to assess the real-world effectiveness of inclisiran alongside usual care in a typical U.S. patient population with atherosclerotic cardiovascular disease. Participants will be randomly assigned to receive either 300 mg inclisiran or a matching placebo by subcutaneous injection on Day 1, Month 3, and then every 6 months thereafter. The first dose is given within 14 days of a successful percutaneous coronary or peripheral endovascular intervention. Both groups will continue to receive standard medical care as directed by their physicians. The study plans to enroll about 6,000 participants and treatment duration may last up to approximately 45 months. During the study, researchers will monitor participants for the occurrence of major adverse cardiovascular events and major adverse limb events for up to about 4 years. Participants will have regular follow-up visits and safety assessments throughout the study period, which is designed to continue until around 2,380 primary events have occurred or at least half the participants have completed 36 months of follow-up. Outcome measures focus on the number of cardiovascular and limb events after the procedures, providing important information on the long-term impact of inclisiran in this patient group.

Researchers are conducting a prospective, multicenter clinical study to evaluate the effects of the IntraOsseous BioPlasty4 (IOBP4) surgical technique in treating symptomatic subchondral bone pathology (SBP) of the knee. The study includes both male and female patients diagnosed with SBP who have not improved with conservative treatments. The goal is to assess clinical outcomes and patient-reported measures, with a focus on whether this technique can prevent the need for further knee surgeries such as knee replacement or other stabilization procedures over five years. Participants will receive the IOBP4 procedure, which involves injecting a biologic mixture of bone marrow concentrate and allograft into the subchondral bone lesion in the knee. Eligible subjects are those scheduled for this surgical intervention and confirmed to have a single SBP lesion in the tibia or femur through MRI. The study will enroll adults aged 18 to 60 years with stable knee ligaments, neutral alignment, and significant pain. During the study, participants will be closely monitored to evaluate adverse events and the prevention of additional knee surgeries over five years. Assessments will include imaging and patient-reported pain scores, with follow-up visits to ensure safety and track clinical outcomes. The study aims to provide detailed information on the effectiveness and safety of the IOBP4 technique for treating knee subchondral bone lesions.

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.