Biella

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as 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 the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

Researchers are studying colorectal cancer CRC patients to understand the interactions between tumor and host cells and how these affect patient outcomes like recurrence and survival. This observational study aims to collect detailed clinical and molecular data from a mixed group of CRC patients to improve future treatments and support experimental trials. The study is designed as a flexible infrastructure with multiple tiers to capture the biological changes driving tumor evolution. Participants are followed longitudinally for at least five years or until death, with data and samples collected at various points during their treatment journey. Patients enter the study either before surgery or before starting systemic therapy, prioritizing those without prior metastatic treatment. The study collects diverse biological samples and clinical data, including imaging, to monitor disease progression and develop experimental models and companion diagnostics. During the study, participants will undergo regular data and sample collection such as tissue biopsies, blood draws, stool samples, and imaging tests. Researchers will track the number of patients monitored over six months and the number triaged into proof-of-concept clinical trials. The study emphasizes careful monitoring, modeling, and linking of patient data to understand tumor evolution and response to treatments over time.

Researchers are studying metastatic breast cancer in a program aiming to recruit 1300 patients from hospitals across Europe. Eligible participants are adults aged 18 or older, male or female, with a recent diagnosis of metastatic or locally advanced breast cancer or disease relapse who have not received more than one type of treatment for metastases. The goal is to better understand genetic changes in metastatic breast cancer and discover how tumors respond or resist therapy to eventually identify the most suitable treatment for each patient. The study is sponsored by the Jules Bordet Institute and focuses on molecular analysis of cancer samples. Participants will undergo a biopsy of a metastatic lesion either at program entry or up to six months before inclusion, and a sample of the primary tumor must be available. Blood, serum, and plasma samples will also be collected. These samples will be analyzed centrally, and any unused samples will be stored in a bio-repository for future research. The study offers the possibility for patients with certain genetic changes to join related clinical trials if available and approved in their country. Throughout the study, participants provide blood samples at screening and regular intervals during follow-up. Researchers will evaluate genetic alterations, identify exceptional responders and rapid progressors, and assess patient prognosis over up to 10 years. The study will also monitor the feasibility of molecular screening and correlate molecular findings with standard measures of treatment response. The total study duration extends to March 2031, with primary outcome review planned one year after recruitment ends.

Researchers are conducting a phase III randomized clinical trial to study early stage Follicular Lymphoma, a type of lymphoma that has not been treated before. The trial compares the effects of local Radiotherapy alone versus Radiotherapy combined with the drug Obinutuzumab. The goal is to better understand how these treatments work for patients with early stage Follicular Lymphoma and to evaluate progression-free survival and other outcomes. Participants will be randomly assigned to one of two groups one group will receive involved-site Radiotherapy at a standard dose of 24Gy alone the other group will receive the same Radiotherapy followed by Obinutuzumab infusionsfour weekly doses plus four additional doses every three weeks, totaling eight doses. This open-label study is conducted across multiple centers. During the study, participants will be monitored for treatment response and side effects over a period of up to 45 months, including 9 months of treatment and 36 months of follow-up. Assessments include imaging scans, laboratory tests, and molecular analyses to evaluate response rates, disease progression, and molecular markers. Safety and adverse events will be tracked throughout, with long-term follow-up to understand treatment effects and disease status.

Myelodysplastic syndromes MDS primarily affect older adults and involve problems with blood cell production, leading to anemia, low white blood cells, and low platelets. These conditions often cause patients to depend on red blood cell transfusions and carry risks like infection and bleeding. This research evaluates luspatercept, a protein designed to help mature red blood cells, in adults with MDS who have a specific chromosome deletion del5q and who are resistant or intolerant to prior treatments like lenalidomide. The study focuses on patients with low to intermediate risk MDS and aims to assess whether luspatercept can reduce the need for transfusions. Participants will receive luspatercept injections under the skin every three weeks, starting at a dose of 1.0 mgkg, with possible increases up to 1.75 mgkg. The study has a screening period, followed by a two-year treatment phase where patients receive the drug and are closely monitored. After treatment, there is a three-year follow-up to observe longer-term effects. Researchers will track responses such as transfusion independence, hemoglobin levels, quality of life, and safety during and after treatment. Throughout the study, participants will have regular visits for assessments including blood tests, quality of life questionnaires, and monitoring for side effects. The main outcome is whether patients achieve at least eight weeks without needing red blood cell transfusions within the first 24 weeks. Additional measures include long-term transfusion independence, duration of response, reduction in transfusions, changes in iron levels, and overall safety over five years. The total participation lasts up to five years, ensuring comprehensive evaluation of luspatercepts effects.

Researchers are studying the effect of combining environmental visual distraction with nitrous oxide NO analgesia on patients undergoing outpatient operative hysteroscopy. This randomized pilot clinical study focuses on women aged 25 to 60 who need hysteroscopy for diagnosing or treating uterine conditions. The goal is to see if relaxing visual scenes during the procedure can reduce pain and improve patient comfort compared to using nitrous oxide alone, which is a routine pain relief method. Participants will be randomly assigned to one of two groups. One group will receive nitrous oxide analgesia combined with a virtual environmental windowa wall-mounted screen showing calming videos like natural landscapes or ocean scenes starting about 5 minutes before and during the procedure. The other group will receive nitrous oxide analgesia alone without any visual distraction. The study compares these two approaches to assess their impact on the procedural experience. During the study, participants will undergo outpatient hysteroscopy while receiving the assigned interventions. Immediately after the procedure, they will complete a Visual Analogue Scale VAS to rate their pain intensity. Researchers will also collect clinical and procedural data for analysis. The study will monitor referral rates to the operating room and consider factors like parity and the type of hysteroscopic instrument used. The entire process follows ethical standards and data protection regulations, with outcome assessors blinded to group assignments.

Researchers are evaluating the use of intracoronary optical coherence tomography OCT guidance compared to angiography-only guidance during percutaneous coronary intervention PCI to treat coronary in-stent restenosis ISR. ISR remains a challenge despite advances in drug-eluting stents, and this trial aims to understand whether OCT can improve acute PCI outcomes by providing more detailed imaging guidance. The study is a randomized, multicenter, non-blinded trial including patients with acute coronary syndrome or stable ischemic heart disease who have ISR requiring PCI. Participants will be randomly assigned to one of two groups PCI guided by OCT plus angiography or PCI guided by angiography alone. In the OCT group, operators perform at least one OCT imaging run before and after PCI and may perform additional OCT runs during the procedure. In the angiography-only group, operators perform PCI guided by angiography, but OCT imaging is also done before and after PCI without the operator seeing the results to allow outcome comparison. Operators use standard PCI tools and techniques at their discretion in both groups. During the study, participants undergo diagnostic angiography followed by PCI with assigned imaging guidance. Researchers will assess the cross-sectional area of the treated coronary segment before and after PCI using imaging techniques. Additional data collected include the number of PCI maneuvers, intracoronary devices used, and quantitative flow ratio values. Participants will be followed for one year to monitor major adverse cardiovascular events. The total participation period includes the PCI procedure and follow-up evaluations up to one year post-procedure.

Mild traumatic brain injury TBI is a common reason for visits to emergency departments EDs. Researchers are studying how brain computed tomography CT scans are used in Italian EDs to assess patients with mild TBI. The study aims to understand the variability in CT use, validate existing clinical decision tools, and develop a new model to predict medium-term outcomes for patients with mild head trauma. The study observes adult patients who come to the ED with mild head trauma, defined by a Glasgow Coma Scale score between 13 and 15. Patients with longer-lasting loss of consciousness or amnesia are excluded. Researchers will analyze when and how CT scans are used and compare this with guidelines such as the Canadian CT Head Rule and others. They will also validate current scoring systems and work on creating an improved decision-making tool to help doctors decide when CT scans are necessary. Participants will be monitored from September 2025 through August 2027. During this time, researchers will assess CT scan use, validate common scoring methods, and develop a new score. The study involves reviewing patient data and clinical outcomes to better understand the best practices in managing mild TBI in the ED. This research aims to improve patient care by reducing unnecessary CT scans while identifying those at risk of serious complications.

Researchers are investigating advanced follicular lymphoma FL by studying the role of EZH2 gene changes in patients treated with immunochemotherapy. This study is linked to the FILFOLL12 trial, which enrolled 807 patients and compared first-line treatments using chemoimmunotherapy combinations like R-CHOP or bendamustine-rituximab BR. The goal is to find biomarkers that can guide doctors in selecting the best chemotherapy approach for each patient. The study involves analyzing biological samples such as bone marrow, peripheral blood, and diagnostic tumor tissue. Tests include detecting EZH2 mutations using droplet digital PCR and examining gene expression patterns with RNA sequencing. Researchers will also explore other markers related to disease diversity, minimal residual disease, genetic factors, and microbiome profiles. These tests build on samples collected during the original FILFOLL12 trial. Participants have already been enrolled in the FILFOLL12 trial and provided biological samples. Researchers will measure outcomes like progression-free survival up to 43 months after treatment start, response rates within several months, and the relationship between gene mutations and expression patterns. The study is observational and focuses on laboratory analyses without additional treatments. It aims to provide practical biomarkers for clinical use and establish a network of laboratories for timely testing.

This research aims to evaluate the effects of adding Vitamin D supplementation to standard immunochemotherapy in elderly patients diagnosed with Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma. This open-label, randomized phase III trial compares two treatment approaches to understand whether Vitamin D affects outcomes in patients aged 65 and older undergoing immunochemotherapy. Participants are randomly assigned to one of two groups. Both groups receive a prephase of oral prednisone followed by six cycles of immunochemotherapy with R-CHOP or R-miniCHOP every 21 days. The experimental group also receives Vitamin D supplementation starting before treatment and continuing through immunochemotherapy according to a set schedule, including loading doses based on baseline Vitamin D levels and weekly maintenance. Patients may continue Vitamin D supplementation after treatment for up to two years. During the study, participants undergo baseline assessments and are monitored regularly through the treatment cycles. Researchers track progression-free survival over 54 months as the primary outcome, along with overall survival, response rates, Vitamin D levels, physical functioning, and fatigue. Safety and treatment adherence are also monitored, with follow-up visits extending up to several years to evaluate long-term outcomes.