Cagliari

Researchers are evaluating two different surgical tools, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for a dual wavelength diode laser, to perform hysteroscopic polypectomy in an outpatient setting. This study aims to compare these instruments by measuring procedure duration, additional instrument use, procedure effectiveness and safety, specimen quality for histology, overall suitability, patient pain and anxiety levels during the procedure, and changes in quality of life after treatment in women with suspected endometrial polyps. Participants will undergo medical history and gynecological evaluation, followed by transvaginal ultrasound to assess the polyp's characteristics. During the outpatient procedure, patients will have diagnostic and operative hysteroscopy without anesthesia using a 5 mm rigid hysteroscope. Polypectomy will be performed using either the 5 Fr bipolar electrode or the 5 Fr angled conical optical fiber, with the choice made by the operator. The procedure will be video recorded, and parameters such as procedure time, use of accessories, and operator evaluations of cutting precision and specimen adequacy will be collected. After the procedure, patients will be monitored for 30 minutes and assessed for pain and anxiety using standardized scales. Follow-up at 60 days includes ultrasound evaluation for residual tissue, quality of life questionnaires, and recording of any surgical complications. This detailed monitoring aims to assess the performance, safety, and patient experience of the two tools over the entire study period.

Researchers are conducting an international multicenter retrospective observational study to better understand the progression and clinical outcomes in patients with Essential Thrombocythemia (ET) who have the JAK2V617F mutation and later develop Polycythemia Vera (PV). The study follows updated 2022 diagnostic criteria for these myeloid blood disorders and includes two parts: a nested case-control study and a comparative retrospective cohort study. In the first part, patients who progressed from ET to PV by the end of 2020 are matched 1:1 with ET patients who have the same mutation but did not progress, based on year and age at ET diagnosis and disease duration. The second part compares patients with newly diagnosed PV who never had ET, matched similarly by year and age at diagnosis and disease duration, ensuring at least 5 years of follow-up for these patients. Participants' medical records will be reviewed retrospectively to compare clinical features and outcomes up to their baseline dates. The study aims to clarify phenotypic changes and clinical results in these patient groups. No interventions are administered, and the study focuses on analyzing existing data to assess progression and outcomes in these blood conditions.

Researchers are exploring how machine learning can improve the prediction of early disease recurrence in patients with multiple myeloma (MM), a complex blood cancer. Despite advances in treatment that have improved survival and deep clinical responses, some newly diagnosed MM patients still face a higher risk of disease progression within 12 months of starting therapy. Current risk scores use limited clinical and biological information, so this study aims to develop more accurate predictive models by integrating clinical, genomic, and imaging data through advanced machine learning techniques. The study is observational and non-interventional, conducted across multiple centers nationally. It will collect and analyze diverse data from MM patients using machine learning to identify patterns and clusters that correlate with early progression or relapse. By combining tumor and immune biomarkers from high-throughput and omics technologies, the study hopes to create models that better stratify patients based on their individual risk profiles without changing their treatment. Participants will be monitored to measure their overall response rate to therapy at 12 months after starting treatment. The study focuses on gathering detailed patient information to support improved clinical decision-making and personalized treatment approaches. Results could help identify patients at high risk upfront, potentially guiding more effective management and benefiting the healthcare system through tailored care strategies.

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.

Researchers are evaluating whether baricitinib can delay the onset of clinical stage 3 type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or multiple diabetes-related autoantibodies indicating increased risk. The study aims to measure the time from the start of the trial to diagnosis of stage 3 type 1 diabetes, with participation lasting up to approximately 5 years. Participants will be randomly assigned to receive either baricitinib or a placebo, both administered orally. The trial compares these two groups to assess the impact of baricitinib on delaying progression to stage 3 T1D. The study's design includes careful monitoring of participants over time to evaluate the effects of the medication or placebo on disease development. During the study, participants will undergo regular assessments to detect the progression of diabetes, including laboratory tests for autoantibodies and clinical evaluations. Researchers will track the time it takes for participants to develop stage 3 T1D, along with monitoring safety and any adverse effects. The total duration of participation can be up to 5 years, ensuring thorough observation of long-term outcomes related to the study interventions.

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.