St. Helena

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are evaluating the CellFX nsPFA Cardiac Surgery System for treating atrial fibrillation AF in adults undergoing heart surgery. This prospective, multicenter, non-randomized single-arm study focuses on adults aged 18 to 85 with paroxysmal or persistent AF who are scheduled for cardiac surgery involving cardiopulmonary bypass. The goal is to assess the safety and effectiveness of this device during concomitant cardiac surgical procedures. Participants will receive cardiac ablation using the CellFX nsPFA Cardiac Clamp system during their open-heart surgery. The procedure includes isolation of the left and right pulmonary veins and the left atrial posterior wall via roof and floor lesions, forming a box lesion set. Left atrial appendage exclusion or removal is also performed. The left atrial posterior wall isolation can be achieved by either an epicardial lesion or a combined epicardial and endocardial approach when the left atrium is open. During the study, participants will be monitored for freedom from atrial arrhythmias lasting more than 30 seconds and freedom from increased use of certain antiarrhythmic drugs from 3 to 6 months after the procedure. Safety is tracked by recording major adverse events such as death, stroke, heart attack, or bleeding within 30 days after surgery. Follow-up includes assessments of electrical isolation immediately after ablation and patient-reported quality of life at 6 and 12 months. The total participation period includes baseline, procedure, and follow-up visits up to 12 months.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

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 collecting Real-World Data to better understand treatment outcomes and health economics related to lesions in the peripheral vasculature. This global, prospective, non-randomized, open-label, multi-center Registry aims to include populations not well represented in previous Peripheral Vascular Disease trials. The study supports the safe use of commercially available Boston Scientific drug-eluting devices for this condition. Participants receive treatment using any eligible commercially available Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. The study includes two cohorts a Clinical Cohort, where patients undergo standard of care assessments with follow-up for up to 2 years in multiple countries and 5 years in China, and an Outcomes Cohort at select sites with additional evaluations including Quality of Life questionnaires, six-minute walk tests, and healthcare utilization data collection. During the study, participants complete various assessments according to standard care and additional tests depending on their cohort. Researchers measure major adverse events and lesion patency at 12 months to evaluate outcomes. The study monitors participants through follow-up visits extending up to 5 years to gather safety and effectiveness data in real-world clinical practice.

Researchers are evaluating two ways of sharing genetic testing results with first-degree relatives of patients newly diagnosed with colorectal cancer. The study aims to determine whether communication by healthcare providers is more effective than communication by the patient themselves in encouraging relatives to undergo genetic testing. This is important because about 15% of colorectal cancer cases have inherited genetic variants that increase cancer risk, and relatives often do not know they may be at risk. Identifying these variants can help relatives take preventive measures.

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 the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for treating non-paroxysmal atrial fibrillation, including persistent and longstanding persistent forms. This multi-center, single-arm, prospective study involves up to 160 participants undergoing concomitant cardiac surgery. The goal is to support an expansion of product labeling for these devices to include treatment of persistent atrial fibrillation. Participants will receive surgical ablation during their planned open-heart surgery. This includes the use of the Cardioblate iRF and CryoFlex hand held devices, with required procedures such as the Cox Maze IV lesion set and closure or amputation of the left atrial appendage. The study does not include a control group and follows patients for 12 months after the procedure. During the study, participants will be monitored for major adverse events up to 30 days post-procedure or hospital discharge and assessed for freedom from atrial fibrillation, atrial flutter, or atrial tachycardia from 6 to 12 months post-procedure. Additional safety and efficacy measures will be collected, including pacemaker implantation rates, quality of life surveys, and procedural success. Follow-up visits and evaluations will continue for 12 months to monitor outcomes and safety.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.