Evergreen Park

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 working to develop a broad test to detect gynecologic cancers, including endometrial, ovarian, and cervical cancers, using specific methylated DNA markers (MDMs) and high-risk human papilloma virus found in vaginal fluid and plasma. This study focuses on Phase II research to identify endometrial cancer and atypical endometrial hyperplasia from vaginal fluid, and ovarian cancer from both plasma and vaginal fluid. It also includes early Phase I studies to explore new cervical cancer markers and test the specificity of these cancer markers among common benign gynecologic conditions. Participants will provide vaginal fluid and blood samples collected by healthcare providers before any examinations or procedures. The study includes several groups based on age and clinical findings, such as patients with abnormal uterine bleeding, biopsy-proven cancers or precursors, abnormal cervical tests, benign gynecologic conditions, wellness exam participants, and those with adnexal masses or suspected ovarian cancers. Each group has specific inclusion and exclusion criteria, and samples will be used to develop and validate predictive models for cancer detection. Throughout the 18-month study, researchers will analyze these samples to create and test models that can accurately identify endometrial and ovarian cancers and their precursors. Participants may undergo standard clinical evaluations and procedures as needed, but the study primarily involves sample collection and medical history review. The main outcomes focus on the performance of the DNA marker models in detecting these cancers within a more diverse participant group.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the real-world effectiveness of durvalumab-based treatments in patients with hepatobiliary cancers, including unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancers (aBTC). This multicountry, multicenter observational study aims to collect contemporary data on these treatments across 22 countries, involving approximately 2500 adult patients. The study focuses on measuring overall survival and other clinical outcomes in routine clinical practice or through early access programs. The study collects data on patients treated with durvalumab-based regimens, including combinations such as STRIDE (Single Tremelimumab Regular Interval Durvalumab) and durvalumab with chemotherapy (e.g., Durvalumab plus GemCis). Data collection includes primary data gathered during routine visits and secondary data from medical records at enrollment and every 6 months. The study includes a baseline period of up to 5 years before starting durvalumab treatment and follows patients for up to 2 years for aBTC and 3 years for uHCC. Participants will have their demographics, clinical characteristics, treatment patterns, concomitant medications, and key outcomes such as real-world overall survival assessed at multiple time points (6, 12, 24 months for both aBTC and uHCC, and 36 months for uHCC). Researchers will also monitor progression-free survival, time to treatment progression, recurrence-free survival, and other clinical endpoints. Safety and follow-up continue until death, loss to follow-up, withdrawal, or study end.

Researchers are evaluating VX-147 for its effectiveness, safety, tolerability, and how the body processes it in adults and children aged 10 to 65 who have apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. This study is a Phase 2/3 trial designed to better understand treatment options for this specific kidney condition. Participants will receive either VX-147 or a placebo, both given as oral tablets. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment period. The trial consists of two parts: Part A focuses on treatment effects over at least 48 weeks, while Part B involves continued safety and tolerability observation for approximately four years after the last participant enrolls. Throughout the study, participants will undergo regular assessments including measurements of urine protein to creatinine ratio and kidney function via estimated glomerular filtration rate (eGFR). Safety is monitored by tracking adverse events and serious adverse events. Data will be collected during the treatment period and followed long-term to evaluate both efficacy and safety outcomes, with some measures assessed at interim and final analyses over at least two years.