Barnstable

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the Freenome Multiomics Blood Test as a tool to help detect lung cancer earlier in people at high risk. This prospective, multi-center observational study involves participants eligible for standard lung cancer screening using a low-dose computed tomography (LDCT) scan. The study collects blood samples and compares the test's results with routine screening to see how well the blood test detects lung cancer over time. Participants who qualify and consent will have 50 ml of blood drawn for analysis by Freenome or its designee. Blood collection is done within 30 days of consent, and ideally on the same day as the LDCT screening, but up to 45 days after blood collection is allowed for the scan. The study collects detailed clinical and demographic information, including medical history, lifestyle, family history, and exposure risks, along with diagnostic and follow-up imaging and pathology reports related to lung cancer diagnosis. Participants will be followed for at least 24 months from their initial screening CT scan or until early study exit due to withdrawal or death. The researchers will monitor the sensitivity and specificity of the blood test in detecting lung cancer during this period. All clinical data, imaging, lab tests, and outcomes related to lung cancer diagnosis will be carefully recorded and analyzed to evaluate the blood test's performance.

Researchers are studying ways to overcome barriers to colorectal cancer screening in community health centers (CHCs) with diverse populations. The study aims to understand the demographics and screening needs of different age groups, including those aged 45-49, 50-54, and over 55. It focuses on identifying disparities in screening based on race, ethnicity, gender, and insurance status by analyzing electronic health records and data from a population management platform. The project also explores perceptions and attitudes about screening practices and potential improvements. The study involves focus groups with CHC staff such as administrative leaders, population health managers, data analysts, nurses, medical assistants, and healthcare providers to identify barriers and facilitators to screening. Based on these findings, researchers will develop and test new strategies at the patient, provider, and system levels using rapid cycle testing methods. These strategies may include technology-based prompts like text messages and workflow changes involving medical assistants. Each health center will test at least two strategies per level to optimize screening approaches. Participants will be involved through focus groups, surveys, and data analysis over a period of about four months. Researchers will collect and analyze data on the acceptability, feasibility, and appropriateness of the implementation strategies. Staff perceptions of these strategies will be evaluated through surveys after testing. This comprehensive approach aims to tailor and improve colorectal cancer screening processes in community health centers to better serve diverse populations.

This research aims to evaluate the long-term safety and effectiveness of the Rigicon Infla10 Inflatable Penile Prosthesis (IPP) in men with erectile dysfunction (ED). ED is a common male sexual disorder associated with reduced quality of life and linked to conditions like diabetes, hypertension, and cardiovascular disease. The study follows patients implanted with the Rigicon Infla10 Pulse Dynamic Inflatable Penile Prosthesis for up to three years, assessing its safety and functional outcomes. Participants receive the Rigicon Infla10 IPP, a three-piece inflatable device designed to help men achieve reliable erections. This device is implanted surgically, and the study tracks patients for up to three years after implantation to monitor device performance and safety. The device aims to provide dependable spontaneity for sexual intercourse. During the study, participants undergo regular follow-up visits that include safety assessments and effectiveness tests. The main safety outcome is the proportion of patients free from device- or procedure-related adverse events of moderate severity or higher within 12 months after surgery. Effectiveness is measured by an objective test of penile rigidity at 12 months. The study also monitors for any complications and collects data on patient adherence and quality of life over the long term.