Barnstable

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the Freenome Multiomics Blood Test as a new way to screen for lung cancer in people at high risk. This observational study includes adults aged 50 and older who are current or former smokers with a significant smoking history. The goal is to see how well this blood test works alongside the standard Low-Dose Computed Tomography LDCT screening to detect lung cancer early. Participants will provide a blood sample of 50 ml that will be tested and stored by Freenome or its designee. They will also undergo a standard LDCT chest scan, ideally on the same day as the blood draw or within 45 days afterward. The study collects additional information such as medical history, lifestyle, environmental exposures, and results from diagnostic tests related to lung cancer detection. Participants will be monitored for at least 24 months following their baseline chest CT scan to track health outcomes. Researchers will review clinical data, imaging reports, and lab results during this period. The main outcome measured is the blood tests sensitivity and specificity in detecting lung cancer at 12 months, with additional measurements at 24 months. The study may end early if participants withdraw or pass away.

This research aims to improve colorectal cancer screening by identifying and addressing barriers in community health centers CHCs with diverse populations. The study focuses on people aged 45 and older, examining baseline screening needs and disparities. Researchers will analyze electronic health records and use focus groups with CHC staff to understand screening challenges and perceptions about screening age changes and strategies. The study also seeks to develop and test ways to improve screening at patient, provider, and system levels using rapid cycle testing. The study involves several steps first, analyzing data from health records and population management platforms to understand screening patterns and resource needs. Second, conducting focus groups with various CHC staff to identify barriers and attitudes toward screening and new strategies like using technology and medical assistant involvement. Third, developing implementation strategies based on these findings and testing them individually at each CHC using a design where each center acts as its own control. Strategies may include patient text messages, staff training, and workflow changes. Participants, who are CHC staff involved in colorectal cancer screening, will engage in focus groups and implementation testing lasting about four months. Researchers will collect data on how acceptable, feasible, and appropriate the strategies are through surveys and observation. They will also measure changes in screening rates. The study uses detailed data management and analysis methods to track progress and outcomes, aiming to tailor and optimize screening interventions in these health centers.

Erectile dysfunction ED is a common male sexual problem linked to reduced quality of life and often occurs alongside conditions like diabetes, hypertension, and cardiovascular disease. Researchers are evaluating the long-term safety and effectiveness of the Rigicon Infla10ae Inflatable Penile Prosthesis IPP in men with ED. This study focuses on patients implanted with the Rigicon Infla10ae Pulsetrade Dynamic Inflatable Penile Prosthesis and follows them for up to three years after implantation. The study involves male participants aged 22 and older who receive the Rigicon Infla10ae three-piece inflatable penile prosthesis as a treatment for ED. There is a single study group which will be monitored after receiving the device. The device is patient-activated to help achieve and maintain an erection, and the study assesses its safety and function over time. Participants will have regular follow-up visits over three years to complete tests and assessments. Researchers will monitor for any device- or procedure-related adverse events during the first 12 months and evaluate penile rigidity at 12 months. Other measures include tracking revision surgeries, erectile function scores, self-esteem scales, and adverse events throughout the study period. Participants must agree to follow all study protocols and attend scheduled visits.