Bergamo

Hepatitis Delta Virus (HDV) is a severe form of chronic viral hepatitis that affects only patients positive for Hepatitis B surface antigen (HBsAg). This research aims to estimate how common HDV infection is among these HBsAg-positive patients hospitalized or receiving care at specific healthcare units in Bergamo, Italy. The study also compares these new findings with previous estimates for patients treated as outpatients. The goal is to improve early identification and management of HDV, which remains underdiagnosed despite clinical guidelines recommending routine testing. The study introduces an "HDV-reflex" screening method starting in 2025, which automatically tests all HBsAg-positive patients for anti-HDV antibodies. This approach, already used successfully in other countries, is expected to increase the number of patients screened, improve referral for antiviral treatment, and help reduce the incidence of advanced HDV-related liver disease over time. The screening is carried out among patients hospitalized in the Department of Medicine at ASST Papa Giovanni XXIII, as well as those attending the SerD and Prison Healthcare Unit in Bergamo. Participants will undergo anti-HDV testing at diagnosis during their hospital stay or clinic visit. Researchers will measure the percentage of patients who test positive for anti-HDV antibodies to determine HDV prevalence. The study requires informed consent and monitors patients within the specified healthcare units. This information will help refine care pathways and treatment strategies for those affected by HDV, ultimately aiming to improve patient outcomes.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the safety and effectiveness of a new light therapy called reSEES to treat intermediate age-related macular degeneration (AMD). The study combines two laser-light treatments, photothermal and photobiological techniques, which are already known to be safe. This investigational device aims to explore the combined therapeutic effects of these two techniques. The primary goal is to confirm the safety of reSEES, while also studying its impact on the progression of intermediate AMD over one year. Participants will receive nine treatments over three weeks during a loading phase. Treatments include selective micropulse laser (SMPL) on days 0, 7, and 14, and photobiomodulation (PBM) on days 0, 3, 7, 10, 14, and 17. Treatment sessions occur twice weekly, with two treatments given on the first visit of each week (SMPL followed by PBM), and PBM alone during the second visit. After treatment, participants will have three follow-up visits at 18, 24, and 54 weeks to monitor progress. During the study, participants will attend a total of 10 visits over 52 weeks. Ophthalmic exams and safety checks are done at screening, treatment days, and follow-up visits. Researchers will measure the absence of laser-light spots using specialized imaging and monitor any treatment-related adverse events. Additional assessments include retinal changes, blood vessel health, vision function, and patient well-being. Health status, medical history, and medications will be regularly reviewed to support study safety and data quality.

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 evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This Phase 3, open-label study aims to monitor the safety of this treatment over an extended period in a pediatric population. Participants will receive guselkumab through subcutaneous injections. The study includes those who have completed the initial pediatric guselkumab dosing and have benefited from continued therapy as judged by their doctor. The study focuses on long-term treatment, with safety assessed by tracking adverse events for up to 6 years and 9 months. During the study, children will be regularly monitored for treatment-emergent adverse events. Parents or guardians will provide consent, and children able to understand will give assent. Researchers will collect data to assess safety throughout the treatment period, ensuring careful observation of participants' health and responses to guselkumab.

This research investigates the long-term effects of mirikizumab in children and adolescents aged 2 to 19 years with moderate-to-severe ulcerative colitis or Crohn's disease. The study is designed as a Phase 3, multicenter, open-label extension trial aiming to assess the ongoing safety and efficacy of this treatment in pediatric participants. It includes those who have completed previous related studies and are expected to benefit from continued mirikizumab treatment. Participants will receive mirikizumab either by subcutaneous injection or intravenous infusion as part of this extended treatment. The study may last approximately 172 weeks and involve up to 44 visits over this period. There is also a possibility for participants to continue receiving treatment through a Continued Access Period after the main study. Throughout the study, participants will be regularly monitored with clinical assessments to determine remission status using the Modified Mayo Score for ulcerative colitis and the Pediatric Crohn's Disease Activity Index for Crohn's disease at week 52. Safety and efficacy will be closely followed, including the evaluation of any adverse events or changes in disease activity, ensuring comprehensive long-term observation.