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Found 6 Actively Recruiting clinical trials

B

Actively Recruiting

Researchers are evaluating how breast density affects the accuracy and outcomes of mammographic breast cancer screening within the regional "Prevenzione Serena" program at ASL CN2, Piedmont, Italy. This observational, retrospective study focuses on women aged 45 to 75 who underwent routine mammograms between September 25, 2023, and May 3, 2024. Breast density, classified by the BI-RADS system (categories A to D), can reduce mammography sensitivity because dense tissue may hide tumors, leading to missed cancers or false-positive results. The study also investigates other factors such as menopausal status, family history, and hormone therapy in relation to breast density and screening outcomes. No treatments or interventions are administered as part of this study. Instead, the study evaluates breast density using the Insight BD automated software integrated into the Siemens Mammomat Revelation mammography system. Insight BD will undergo technical validation with a mammography phantom and diagnostic validation by comparing its breast density classifications to those of two radiologists. The primary focus is on recall rates for second-level exams like ultrasound or MRI, particularly for women with dense breasts (BI-RADS C and D). This research aims to provide evidence for improving screening guidelines and personalized approaches. Participants' mammograms, breast density measures, and clinical data will be reviewed retrospectively. Researchers will assess recall rates for additional testing, the accuracy of the Insight BD software, and the frequency of false-positive recalls, which can cause patient anxiety and increase healthcare workload. The study measures outcomes from September 2023 to May 2024, aiming to inform future breast cancer screening practices, especially for women with dense breast tissue.

Age: 45Years - 75YearsFEMALE
1 location
B

Actively Recruiting

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Age: 18Years +All Genders
187 locations
E

Actively Recruiting

Metastatic breast cancer (mBC) is a common and serious condition affecting many patients worldwide. Emotional distress (ED) is reported by about half of breast cancer patients and can negatively influence treatment adherence, symptom management, and quality of life. This research investigates how baseline emotional distress impacts the outcomes of patients with mBC receiving their first line of treatment, aiming to better understand its effect on therapy effectiveness. Participants will receive first-line treatments based on their breast cancer subtype, including endocrine therapy, chemotherapy, immunotherapy, and targeted therapy. They will be grouped into cohorts depending on their disease characteristics and treatment plans, such as immunotherapy combined with chemotherapy or targeted therapies like CDK4/6 inhibitors and trastuzumab. During the study, patients will complete questionnaires to assess emotional distress and quality of life. Throughout the study, researchers will monitor participants' progression-free survival over two years, focusing on differences related to emotional distress at baseline. Patients will undergo evaluations through specific questionnaires about their emotional and quality of life status. The study includes careful observation of treatment outcomes and safety, providing valuable information on how emotional health relates to treatment effectiveness in metastatic breast cancer.

Age: 18Years +All Genders
37 locations
H

Actively Recruiting

Researchers are conducting a study to continuously evaluate the quality of healthcare provided in semi-intensive care units. The goal is to develop indicators that measure healthcare quality based on data collected from patients in these units and the structural characteristics of the hospitals. This evaluation aims to identify areas of care that need improvement for different types of patients. The study will collect and analyze data over a period of five years. Each year, a report will be produced to show the results and quality levels of care in each semi-intensive care unit. This ongoing monitoring will help assess the care provided and guide improvements. Participants in the study are patients hospitalized in semi-intensive care units. Data related to patient care and hospital structures will be gathered and used to create quality indicators. The outcomes measured include healthcare quality for various patient risk groups, with continuous evaluation from January 2021 through December 2025. Annual reports will track the progress and effectiveness of care in these units.

All Genders
25 locations
O

Actively Recruiting

Researchers are investigating whether the presence of isolated tumor cells in the first lymph nodes near the tumor can provide important information about the future outcomes of patients with low-risk endometrial (uterine) cancer. This study compares a group of patients with isolated tumor cells in their sentinel lymph nodes to a historical group without these cells, focusing on the likelihood of cancer recurrence. The study is observational and involves patients diagnosed with specific grades and stages of endometrial cancer without extensive lymphovascular space invasion. Participants in this study have undergone complete surgical staging, including pelvic sentinel lymph node biopsy and detailed tissue analysis, with no additional treatment given after surgery. The study observes patients with isolated tumor cells defined as very small groups of tumor cells in the lymph nodes, without larger metastases. No new treatments are administered during the study, as it is non-interventional. Throughout the study, patients provide tissue samples and allow researchers to review their medical records. The main outcome measured is recurrence-free survival, tracked for up to five years. This long-term follow-up helps assess whether isolated tumor cells in sentinel lymph nodes affect the chance of cancer returning. The study focuses on careful monitoring without additional treatment to better understand disease outcomes in this patient group.

All Genders
20 locations
S

Actively Recruiting

Researchers are evaluating the drug INCB123667 compared to chemotherapy chosen by investigators in women with platinum-resistant ovarian cancer that shows overexpression of cyclin E1. This Phase 3, open-label study focuses on participants with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have developed resistance to platinum-based treatments. The goal is to observe how these treatments affect progression-free survival and overall survival over a period of up to two years. Participants will receive either oral INCB123667 tablets or chemotherapy selected by their investigator based on protocol guidelines. The study includes women who have had between one and four prior lines of systemic therapy after initial diagnosis and have measurable disease according to RECIST criteria. Prior treatments should include bevacizumab and mirvetuximab soravtansine when appropriate. Archival tumor tissue or a fresh biopsy is required before treatment. During the study, participants will be closely monitored through various assessments to measure treatment outcomes and safety. Researchers will track progression-free survival and overall survival up to two years, evaluating the effectiveness of the treatments. The study excludes participants with certain cancer histologies, uncontrolled cardiac issues, active brain metastases, other progressing cancers, or significant gastrointestinal problems. The total duration includes treatment and follow-up evaluations as defined in the protocol.

Age: 18Years +FEMALEPhase 3
162 locations
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