Evergreen Park

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.

Researchers are evaluating two treatment approaches for diabetic foot ulcers DFUs to determine if adding Omeza Complete Matrix OCM to the standard of care SOC improves the chances of complete wound healing. This open-label study involves adult participants diagnosed with Type I or II diabetes who have DFUs that have not healed significantly with SOC alone. The trial includes a randomized design with a crossover option for participants whose wounds do not fully close after initial treatment. Participants will be randomly assigned to receive either SOC alone or SOC combined with OCM. SOC includes surgical sharp debridement, offloading using a total contact cast TCC or fixed ankle-walker, and proper moisture balance. Those in the SOC group who do not achieve complete wound closure by about 84 days post-randomization may cross over to receive OCM applications weekly for up to 12 visits. The study is conducted across multiple medical centers and gathers data on treatment efficacy while aiding insurance reimbursement decisions. During the study, participants will attend regular visits to receive their assigned treatments and undergo wound assessments, including measuring wound area changes and pain levels. Researchers will monitor complete wound closure within 1 to 12 weeks as the primary outcome. Secondary outcomes include changes in wound size and pain assessment. The total study duration extends up to March 2027, with ongoing follow-up after treatment. Participants must meet specific health and wound criteria and follow protocol requirements throughout the trial.

Researchers are developing a test to detect gynecologic cancers, including endometrial, ovarian, and cervical cancers, by identifying specific methylated DNA markers and high-risk human papilloma virus in vaginal fluid and blood plasma. The goal is to improve early detection, especially for women presenting with abnormal uterine bleeding or postmenopausal bleeding, symptoms often linked to these cancers or their precursors. Early detection is crucial to increase the chances of cure and reduce the need for invasive procedures. The study includes multiple groups of women with different gynecologic conditions such as abnormal uterine bleeding, biopsy-confirmed endometrial or ovarian cancer, cervical abnormalities, benign uterine conditions, and healthy controls. Participants will provide vaginal fluid samples collected by a healthcare provider and blood samples before any exams or procedures. This observational study involves testing these samples for cancer-specific markers to develop and validate predictive models for detecting these cancers. Participants will undergo sample collection and clinical evaluations as part of their usual care, including biopsies or surgery when indicated. Researchers will assess the ability of the methylated DNA marker panels to identify cancer and precancerous conditions with high specificity. The study also monitors false positive rates among women with benign conditions. The total participation time varies depending on the patient group, with key outcomes measured over an 18-month period.

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.

Researchers are conducting a large real-world observational study called LIVER-R to gather data on patients with hepatobiliary cancers, specifically unresectable hepatocellular carcinoma uHCC and advanced biliary tract cancers aBTC. The study aims to evaluate the outcomes of patients treated with durvalumab-based regimens, including combinations like STRIDE and durvalumab plus chemotherapy, as part of routine clinical practice or early access programs. This study is descriptive and noncomparative, focusing on real-world effectiveness and clinical characteristics across multiple countries and centers. The study will collect both primary data during patients routine visits and secondary data from medical records at enrollment and every 6 months. It includes a baseline period of up to 5 years before starting durvalumab treatment and a follow-up period lasting up to 3 years for uHCC patients and 2 years for aBTC patients. Data collected will cover treatment patterns, clinically significant events, concomitant medications, and various real-world clinical outcomes such as survival rates, progression-free survival, time to treatment progression, and recurrence-free survival. Participants will be adults diagnosed with hepatobiliary cancer and treated with durvalumab-based regimens as decided by their physicians. Researchers will monitor overall survival and other outcomes at multiple time points over the follow-up period. Data collection involves routine clinical visits, medical record review, and tracking of treatment and event timelines. The study will provide insights into the real-world use and outcomes of durvalumab therapies for these cancers, with continuous monitoring until death, withdrawal, loss to follow-up, or study completion.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.