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Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating trastuzumab deruxtecan T-DXd as a treatment for adult patients with advanced HER2-positive gastric or gastroesophageal junction GEJ adenocarcinoma who have previously received a trastuzumab-based regimen. This study aims to assess the real-world effectiveness of T-DXd, patient characteristics, treatment patterns, and safety in this population. It also includes data collection on patients receiving conventional therapies for exploratory comparison. This is a non-interventional observational study where patients receive T-DXd or conventional therapies as part of routine clinical care according to approved guidelines SmPC. No investigational drugs are given. The study tracks patients starting T-DXd as a second-line or later treatment and collects data on other therapies such as chemotherapy and immunotherapy used in clinical practice. Participants will be followed for up to approximately 2 years from baseline to monitor outcomes including time to next treatment, changes in treatment, physician-reported safety events, use of prophylactic treatments, and quality of life using validated questionnaires. Data on physician visits, treatment discontinuation, and safety events will also be collected to understand treatment tolerability and patient experience in a real-world setting.

This research aims to create a global registry for mitochondrial disorders to unify previous national registries, allowing worldwide participation and supporting studies on the natural history of these diseases. The project is part of the EU-funded GENOMIT initiative, coordinated by Dr. Holger Prokisch at Technische Universitt Mnchen, and intends to improve the design and execution of clinical trials while promoting the translation of basic research into clinical practice. The study collects data from existing networks such as mitoNET in GermanyAustria and Mitocon in Italy, with the possibility of including other countries. Participants with suspected or confirmed mitochondrial diseases are followed with annual assessments using standardized scales like the Newcastle Mitochondrial Disease Scale for Adults and Children, the Scale for the Assessment and Rating of Ataxia, and measures of disease progression. Participants are monitored over a long period, up to 30 years or until discontinuation or death. Annual evaluations assess disease status and progression. The registry complies with national ethics and data protection rules, managing data access accordingly. This setup aims to support natural history studies and facilitate future clinical trials for mitochondrial disorders worldwide.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

Researchers are evaluating the effectiveness and safety of two treatment strategies for patients newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This international, multicenter, randomized, open Phase III trial compares carboplatinpaclitaxel chemotherapy followed by niraparib alone versus carboplatinpaclitaxel combined with bevacizumab followed by both bevacizumab and niraparib. The study includes patients with high-grade, non-mucinous, non-clear cell epithelial tumors at specific advanced stages who have had surgery or plan chemotherapy with interval debulking surgery. All patients receive an initial cycle of carboplatin and paclitaxel before randomization. After central testing of tumor BRCA status, participants are randomly assigned to one of two arms Arm 1 continues with five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years Arm 2 receives five cycles of carboplatin and paclitaxel plus bevacizumab, then maintenance bevacizumab for up to one year alongside daily niraparib for up to three years. This design aims to determine if adding bevacizumab improves outcomes over the standard treatment. Participants undergo frequent assessments including scans and laboratory tests to monitor progression-free survival and other health outcomes. Researchers also evaluate overall survival, time to additional therapies, treatment-related side effects, and quality of life up to several years after enrollment. Patients attend regular visits for treatment, monitoring, and completion of questionnaires, with safety follow-up 30 days after the last dose. The entire observation period can last up to 66 months after the last patient joins the trial.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

Researchers are evaluating treatments for patients with previously untreated follicular lymphoma who have a FLIPI score of 2 to 5. This phase III, randomized, open-label trial compares the combination of mosunetuzumab and lenalidomide with anti-CD20 monoclonal antibody plus chemotherapy. The study aims to assess the efficacy and safety of these treatments in managing this type of lymphoma. Participants enter a screening period lasting up to 6 weeks before randomization and treatment. Those randomized to the experimental arm receive mosunetuzumab with step-up dosing followed by lenalidomide over an induction phase of about 11 months, then a maintenance phase lasting up to 17 months, totaling around 30 months of treatment. The control arm includes different combinations of anti-CD20 antibodies with chemotherapy drugs CHOP or bendamustine over induction phases of about 5 months, followed by maintenance for up to 22 months, also totaling about 30 months. Patients are not allowed to switch from control to experimental treatments. Throughout the study, participants undergo regular follow-up visits for up to 7 years after the last patient is randomized. Follow-up includes assessments every 3 months for the first two years, then every 6 months for three years, and yearly thereafter. Researchers monitor progression-free survival, overall survival, response rates, adverse events, and other health measures. The total study duration is expected to be around 10 years from the start of enrollment to final follow-up.