Sassuolo

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.

This observational study investigates the impact of surgical centralization and treatment strategies on oncologic outcomes in female patients diagnosed with epithelial ovarian cancer EOC between 2018 and 2023 within the Emilia-Romagna region in Italy. The study aims to compare progression-free survival and overall survival across three time periods before centralization and the COVID-19 pandemic, during the pandemic peak, and during the post-pandemic control phase. This research is conducted by the AUSL-IRCCS of Reggio Emilia and includes both retrospective and prospective components. Participants are grouped based on when they received treatment prior to centralization and the pandemic 2018-2019, during the peak pandemic with changes in care due to resource limitations 2020-2021, and after the pandemic peak reflecting new care standards 2022-2023. No experimental treatments are given, as all patients receive standard care according to routine clinical practice. The study observes variations in surgical approaches, chemotherapy, and use of therapies like Bevacizumab and PARP inhibitors. Throughout the study, participants clinical records and outcomes are reviewed retrospectively, with ongoing clinical follow-up planned for up to five years. Researchers assess survival rates, treatment types, tumor characteristics, recurrence patterns, and use of secondary treatments including surgery and radiotherapy. Data collection includes information from multidisciplinary tumor boards and patient consents. The study spans until June 2031, allowing comprehensive evaluation of long-term outcomes.

Researchers are exploring the clinical benefits and safety of Tropho Tend in treating painful Rotator Cuff Tendinopathy RCT. This study compares two groups one receiving standard rehabilitation physiotherapy and another receiving rehabilitation physiotherapy plus Tropho Tend injections. The investigation is open label and controlled, aiming to assess improvements in pain and function over a 4-month period with 5 scheduled visits. Participants are randomly assigned to either the control group receiving rehabilitation physiotherapy alone or the therapy group receiving Tropho Tend injections in addition to physiotherapy. Tropho Tend is given as three perilesional injections spaced two weeks apart, starting at the baseline visit. Ultrasound evaluations of the tendon are performed at the beginning and end of the study to observe changes. During the study, participants have visits at baseline, 2, 4, 8, and 12 weeks. Pain levels, shoulder function, and patient satisfaction are regularly assessed using tools like the Visual Analogue Scale VAS, Shoulder Pain and Disability Index SPADI, and Single Assessment Numeric Evaluation SANE. Quality of life and adverse events are monitored throughout. The total study duration includes screening, treatment, follow-up, and data analysis, concluding about one year after starting.

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.

Researchers are collecting real-world data on patients undergoing rotator cuff repair using the REGENETEN Bioinductive Implant System. This prospective, single-arm, multicenter registry involves up to 50 centers across the United Kingdom, Europe, and Australia, aiming to enroll up to 400 patients. The study focuses on evaluating clinical and health economic outcomes after surgery for rotator cuff injuries. Participants receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant, a device designed to manage and protect tendon injuries without substantial tendon tissue loss. Patients are treated according to standard medical care, and the study gathers data on their recovery and outcomes over time. Participants will be monitored up to two years after surgery with regular assessments including quality of life, arm and shoulder function, pain levels, and shoulder-specific scores at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Additional data on retear rates, postoperative recovery, sling use, mobilization time, and return to work are also collected. The study provides long-term insight into patient progress following the use of the implant.

Researchers are investigating the relationship between MYC gene changes, lymphoma genetic mutations, and the immune environment in adults with Diffuse Large B-cell Lymphoma DLBCL or High-Grade B-cell Lymphoma HGBCL. These lymphomas are diverse diseases making up over a third of adult lymphomas, with survival rates of around 60-70% over five years. The study aims to better understand these genetic factors and their impact on disease outcomes to improve treatment approaches. This observational study includes patients diagnosed with DLBCL or HGBCL who have MYC gene rearrangements or increased MYC gene copies. Participants have received standard first-line chemotherapy treatments such as R-CHOP or intensified regimens. The study collects data retrospectively and prospectively to explore genetic markers, immune cell patterns, and clinical outcomes related to these MYC changes and other genetic alterations. Participants provide tissue samples and clinical information, which researchers analyze for genetic and histological features. The study evaluates how these factors relate to patient responses and survival over up to 36 months. Researchers also review treatment types, risk of disease recurrence, and the effectiveness of preventive therapies. The study spans from diagnosis after January 2019 through long-term follow-up, helping to identify potential prognostic and predictive markers in lymphoma.

Researchers are evaluating how a healthy lifestyle implemented through a Survivorship Care Plan LS-SCP may affect the quality of life for long-term lymphoma survivors who have been in remission for at least three years and up to ten years. The study focuses on patients with classical Hodgkin lymphoma, Diffuse Large B-cell lymphoma DLBCL, or Primary mediastinal large B-cell lymphoma PMBCL who have completed first-line therapy and are aged between 18 and 50 years. This randomized, open-label, multicenter trial aims to understand the impact of lifestyle changes on survivors well-being over time. Participants are randomly assigned to one of two groups the experimental arm receives a Survivorship Care Plan including a nutritional plan and physical activity guidance for six months, with bi-monthly automated calls to support adherence. The control arm receives no specific intervention and follows standard clinical care with self-administered questionnaires at 6 and 12 months. Both groups complete assessments using validated questionnaires at baseline, 6 months, and 12 months to evaluate various health and quality of life measures. During the study, participants undergo clinical assessments and complete questionnaires such as the EORTC QLQ-C30, SF12, MEDI-LITE, Chronic Fatigue Syndrome Self-assessment, Fatigue Assessment Scale, and Hospital Anxiety and Depression Scale. Researchers will monitor outcomes including global quality of life, psychosocial well-being, fatigue frequency, cognitive function, metabolic health, cardiovascular events, adherence to healthy behaviors, and overall survival for up to 30 months from study start. The study includes safety follow-up and compliance tracking to understand how lifestyle interventions might support long-term health in lymphoma survivors.

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.