Biella

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 conducting the AlfaOmega study to better understand how colorectal cancer (CRC) tumors and the patient's body evolve together. The goal is to improve patient outcomes by reducing recurrence risk and enhancing survival. This study will create a detailed clinical and molecular resource by tracking tumor spread over time and space in patients with colorectal cancer, supporting future experimental trials. The study will observe at least 500 patients with various stages of colorectal cancer over their treatment course, continuing for a minimum of five years or until death. Patients enter the study at two key points: before surgery or before starting systemic therapy, prioritizing those new to metastatic treatment. AlfaOmega is organized into three tiers: monitoring patient progress and collecting clinical data and samples, developing experimental models from fresh biological materials, and linking collected data to experimental therapy trials. Participants will undergo ongoing clinical assessments, imaging, and collection of different biological samples such as tissue blocks, blood, stool, and swabs. These data and samples will be used to track tumor evolution, discover new biomarkers, and understand resistance to treatments. The primary outcome is the number of patients monitored longitudinally over six months. The research aims to enable precise and personalized approaches for colorectal cancer treatment through detailed observation and data collection over time.

Researchers are studying metastatic breast cancer by recruiting 1300 patients from many hospitals across Europe. This study focuses on patients aged 18 or older, both female and male, who have been diagnosed with metastatic breast cancer or a relapse and have not received more than one systemic treatment since the discovery of metastases. The main goal is to better understand the genetic changes in metastatic breast cancer and how patients respond or resist therapies, aiming to find the right treatment for each patient. Patients with genetic changes that match new drug trials may have the option to participate in those trials if available. Participants undergo a biopsy of the metastatic lesion to collect tissue samples, performed by a surgeon or radiologist. Biopsy samples, along with blood, serum, and plasma, are collected both at the start and during follow-up. Some samples are analyzed immediately, while others are stored in a bio-repository for future research. Biopsies can be from bone or brain tissue under specific conditions, and must be collected before starting or changing systemic treatment lines, following precise timing rules. Throughout the study, participants provide regular blood samples and allow collection of tissue samples from both primary and metastatic tumors. Researchers monitor participants' health status and treatment responses. The primary outcome is to improve understanding of metastatic breast cancer over the year following the end of patient recruitment. This research aims to enhance treatment outcomes for all patients diagnosed with metastatic breast cancer by using detailed molecular analyses and offering access to clinical trials when possible.

The trial investigates early stage Follicular Lymphoma (grades I-IIIA) in patients who have not received prior treatment. It is a prospective, multicenter, open-label, phase III randomized clinical trial comparing two treatment approaches. The study aims to evaluate the progression-free survival over up to 33 months, including a 9-month treatment period followed by 24 months of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive standard involved-site radiation therapy at a dose of 24 Gy. The second group will receive the same radiation therapy followed by obinutuzumab infusions: 4 weekly doses and then 4 additional doses every 3 weeks, totaling 8 doses. This design allows comparison of radiation alone versus radiation combined with obinutuzumab. During the study, participants will have assessments including PET/CT scans for staging, bone marrow biopsies, and blood tests for specific lymphoma markers. Performance status will be monitored, and liver and kidney function will be evaluated. Safety and effectiveness will be tracked throughout treatment and for two years afterward. The main outcome measured is progression-free survival from treatment start through the follow-up period.

Myelodysplastic syndromes (MDS) are a group of blood disorders mainly affecting older adults, causing ineffective blood cell production leading to anemia and other blood-related issues. This trial focuses on patients with MDS who have a specific chromosome 5q deletion (del5q) and are dependent on red blood cell (RBC) transfusions. These patients have low to intermediate risk disease and have not responded well or cannot tolerate prior treatment with lenalidomide. The study aims to evaluate the effect of luspatercept, a drug that helps mature red blood cells, on reducing the need for RBC transfusions in this group. Participants will receive luspatercept injections under the skin every three weeks, starting at a dose of 1.0 mg/kg with the possibility to increase the dose up to 1.75 mg/kg. The study includes a screening period, followed by a two-year treatment phase where participants get these injections. After completing treatment, participants will undergo follow-up visits every 24 weeks for up to two years to assess ongoing clinical benefits. During the study, participants will be monitored closely with regular visits to check their blood counts and overall health. Researchers will measure how long participants can avoid RBC transfusions over 24 weeks and evaluate safety and other health outcomes. The total participation time includes screening, treatment for two years, and follow-up for an additional three years, ensuring comprehensive monitoring of treatment effects and safety.

Researchers are evaluating whether adding environmental visual distraction to nitrous oxide analgesia can improve the experience of women undergoing outpatient operative hysteroscopy. This procedure is commonly used to diagnose and treat uterine conditions such as abnormal bleeding and infertility. Although recent advances allow many hysteroscopies to be done without general anesthesia, pain and anxiety can still limit patient tolerance and successful completion of the procedure. Participants will be randomized into two groups: one receives nitrous oxide analgesia combined with a virtual environmental window displaying relaxing scenes on a wall-mounted screen, while the other receives nitrous oxide alone as part of routine care. The visual distraction starts about 5 minutes before the hysteroscopy and continues throughout. Nitrous oxide is administered via a buccal-nasal mask beginning approximately 5 minutes prior and maintained during the procedure. During the study, patients' pain intensity will be measured immediately after the hysteroscopy using a Visual Analogue Scale (VAS). Clinical and procedural data will be collected and analyzed with outcome assessors blinded to treatment groups. The study also tracks referrals to the operating room and analyzes results by parity and hysteroscopic instrument used. The total study includes 50 women aged 25 to 60 years, with informed consent and eligibility for nitrous oxide analgesia. Ethical standards and data protection regulations are followed.

Researchers are investigating the treatment of coronary in-stent restenosis (ISR), a condition where the artery narrows again after stent placement, despite advances in drug-eluting stents. This trial compares two methods of guiding percutaneous coronary intervention (PCI) for ISR: one using intracoronary optical coherence tomography (OCT) along with angiography, and the other using angiography alone. The goal is to understand whether OCT guidance improves acute PCI performance for ISR patients. Participants with ISR showing 70% to 99% narrowing in a vessel between 2.25 and 5.75 mm will be randomly assigned to two groups. The first group will have PCI guided by OCT and angiography, with OCT runs before and after PCI, and additional OCT imaging allowed during the procedure. The second group will have PCI guided only by angiography, but OCT imaging will still be performed before and after PCI without the operator seeing the OCT results to maintain blinding. Operators in both groups may use various approved tools and techniques during PCI as needed. During the study, patients will undergo imaging and PCI procedures with detailed documentation of the treatment plans and any changes after OCT review. Researchers will measure changes in artery cross-sectional area after PCI as the primary outcome. Safety and procedural details will be closely monitored. The total participation includes the PCI procedure and follow-up imaging to assess treatment effectiveness.

Researchers are studying advanced follicular lymphoma (FL) to better understand the role of EZH2 gene changes in patients treated with immunochemotherapy. This study is linked to the FIL_FOLL12 trial and aims to find useful biomarkers that can help doctors decide the best chemotherapy combined with anti-CD20 immunotherapy for first-time treatment of advanced FL. The study also explores other new biological markers related to FL. The study involves testing for EZH2 mutations and copy number alterations using a special PCR method on blood and bone marrow samples collected at the start. Additionally, gene expression related to EZH2 will be measured in some tumor tissue samples. These tests help characterize the biological features of the lymphoma and its variations. Participants have already been enrolled in the FIL_FOLL12 trial, and their biological samples such as bone marrow, blood, and tumor tissue are used for these tests. Researchers will analyze these samples to assess progression-free survival up to 43 months from treatment start. The study seeks to provide rapid and practical biomarker results to improve treatment decisions for patients with advanced FL.

Researchers are conducting an open-label, multicenter, randomized phase III trial to compare two treatment approaches in elderly patients aged 65 and older with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular grade IIIb lymphoma. The study evaluates the addition of vitamin D supplementation to a standard prephase treatment with oral prednisone, followed by six cycles of immunochemotherapy with either R-CHOP or R-miniCHOP. The study aims to explore the effects of vitamin D supplementation during immunochemotherapy in this patient population, with a focus on progression-free survival over 54 months. Participants are randomly assigned in a 1 to 1 ratio to either the standard arm (Arm A) or the experimental arm (Arm B). Both arms receive a prephase of oral prednisone for 7 days followed by six 21-day cycles of immunochemotherapy with R-CHOP or R-miniCHOP. Patients in Arm B also receive vitamin D3 (cholecalciferol) supplementation starting with a loading dose based on baseline vitamin D levels, followed by weekly maintenance doses throughout immunochemotherapy and the option to continue monthly supplementation for up to two years. Adjustments to vincristine dosing during prephase and immunochemotherapy are allowed based on clinical judgement. Throughout the study, participants undergo baseline assessments and regular monitoring including vitamin D levels, treatment toxicity, and response evaluations. Patients experiencing treatment-related delays longer than four weeks discontinue study treatment but continue survival follow-up. The primary outcome measure is progression-free survival assessed at the end of treatment and up to 54 months. The study also includes safety monitoring and long-term follow-up to assess sustained outcomes and adverse events.

Researchers are assessing the lasting immune responses from COVID-19 vaccines and other vaccines (zoster, diphtheria, tetanus) in patients with Follicular Lymphoma who require frontline induction immuno-chemotherapy and anti-CD20 maintenance treatment. These patients are at higher risk for severe COVID-19, especially when treated with anti-CD20 monoclonal antibodies, which can reduce antibody responses to vaccination. The study seeks to understand both cellular and humoral immunity persistence, as well as the impact of these treatments on immunity to other vaccines. Participants will be part of the FIL_FOLL19 study and receive standard frontline induction immuno-chemotherapy followed by anti-CD20 maintenance. Blood samples will be collected before treatment starts and at scheduled times during therapy to evaluate immune responses against SARS-CoV-2, Varicella Zoster Virus, diphtheria, and tetanus. Specific laboratory tests will measure cellular immunity using ELISpot assays and humoral immunity using ELISA assays. Additional evaluations include T-cell population and marker analysis by flow cytometry. During the study, patients will complete questionnaires about their vaccination and infection history and receive blood draws at various timepoints. The research team will analyze vaccine-induced immune responses at baseline, during treatment, and up to 12 months after the end of induction therapy. The main outcome is the rate of patients maintaining cell-mediated immunity after about eight months from treatment start. This detailed monitoring aims to better understand long-term immunity in this vulnerable group.