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Researchers are evaluating a "wait-and-see" approach for patients with rectal cancer who respond completely to neoadjuvant chemoradiotherapy. This study aims to provide both short-term and long-term data on cancer control and patient function when surgery is avoided in good responders. The research also seeks to establish a national network of expert centers to improve organ-preserving care and create a registry to gather more evidence about this treatment strategy. The standard treatment for locally advanced rectal cancer typically involves chemoradiotherapy followed by surgery. In this study, patients who show a complete clinical response after treatment will be observed without immediate surgery under a "wait-and-see" policy. The study is a multicenter prospective observational cohort and implementation study, focusing on patients aged 18 or older who have had a long course of chemoradiotherapy or a short course with a long waiting interval. The main goal is to track disease-free survival without tumor regrowth over two years. Participants will be closely monitored using clinical exams, endoscopy, and advanced MRI scans to confirm their response and detect any regrowth early. Researchers will measure outcomes such as two-year disease-free survival, regrowth rate, local control, overall survival, quality of life, and the ability of centers to provide high-quality organ preservation care. Patients will undergo intensive follow-up to ensure safety and gather comprehensive data on the effects of this less invasive approach over time.

Only about 25% of Belgian adults aged 25 to 50 with type 1 diabetes mellitus (T1DM) achieve good blood sugar control, partly due to the daily challenges of managing the condition. Maintaining tight glucose control is essential to prevent serious health complications. While continuous glucose monitors help, managing daily glucose levels remains difficult. Alongside monitoring blood sugar, a healthy lifestyle that includes enough physical activity, limited sedentary time, and good sleep is important for controlling glucose. This research aims to explore how daily 24-hour movement behaviors relate to glucose control and heart health in adults with T1DM. The study involves 150 adults with T1DM who will wear an Actigraph accelerometer for 14 consecutive days to track movement behaviors throughout the day. Participants will continue using their own continuous glucose monitors to measure daily glucose control. Additional information will be collected through questionnaires, diaries, and physical measurements such as blood pressure, weight, height, advanced glycation endproducts, and waist and hip circumference during a single visit at either the University Hospital of Ghent or the University Hospital of Antwerp. This cross-sectional observational approach focuses on understanding the link between daily behaviors and glucose control. Participants will be monitored for about one year on average, with primary outcomes including 24-hour movement behaviors, glucose variability (coefficient of variation), and time spent within target glucose ranges. The data collected will help researchers understand how day-to-day activity patterns affect glucose management and cardiometabolic health. This study's results aim to guide future interventions that promote healthier 24-hour movement habits to improve glucose control in adults with T1DM.

Researchers are evaluating the safety, effectiveness, best dose, and how the body processes (pharmacokinetics) an investigational drug called BNT326. This study includes people with advanced solid tumors that are metastatic, recurrent, or have progressed after previous treatments. The investigation is divided into two parts: Part 1 tests BNT326 alone, and Part 2 studies BNT326 alone or combined with other immunotherapy drugs, including pumitamig (BNT327). Participants have specific tumor types like melanoma, non-small cell lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer, among others. In Part 1, participants receive BNT326 by intravenous infusion in various groups based on cancer type and prior treatments. Part 2 involves BNT326 given alone or with pumitamig, also by intravenous infusion, in several defined cancer groups. Some groups are randomized to receive different dose levels or combinations to find the optimal treatment plan. The study includes a screening phase, treatment phase lasting up to 24 months or until progression or unacceptable side effects, a safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 38 months for Part 1 and 48 months for Part 2. During the study, participants undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and serious adverse events up to months after treatment ends, and measuring drug levels in the blood. Researchers track treatment interruptions or discontinuations due to side effects and evaluate dose-limiting toxicities. Tumor tissue samples are required before enrollment. Safety and effectiveness data are collected throughout treatment and follow-up periods to understand how well BNT326 works alone or combined and its safety profile.

Researchers are studying BAY 3713372, a new drug being developed to treat solid tumors with a specific genetic change called MTAP deletion. The drug works by blocking a protein called PRMT5, which may kill cancer cells with this deletion while sparing normal cells. This first-in-human study aims to understand the safety, how the body processes the drug, and its effectiveness in people with these MTAP-deleted solid tumors. Participants will receive BAY 3713372 orally every day. The study starts with a dose escalation phase, where different groups get increasing doses to find a safe and effective dose. After this, a dose expansion phase will include more participants receiving the drug alone or with other treatments. Participants can continue treatment as long as they benefit and do not experience severe problems. During the study, participants will visit the study site multiple times before and during treatment, and follow-up visits after treatment ends. Doctors will monitor health through blood and urine tests, heart checks with electrocardiograms, and imaging scans like CT or MRI to track cancer changes. Tumor samples may also be taken. Safety and treatment response will be closely assessed, including adverse events and how the drug behaves in the body. Participants will be contacted every three months for up to two years after treatment to check their health.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are evaluating acute respiratory infections (ARI), the most common reason for community healthcare visits, in adults and children across Europe. The study aims to describe ARI cases caused by known and emerging respiratory pathogens in primary care settings, building a research infrastructure for future studies on ARI treatment, diagnosis, and prevention. This long-term observational study includes both a flexible annual audit (POS-ARI-PC AUDIT) and a detailed prospective study (POS-ARI-PC CORE) to capture comprehensive data on ARI presentation and management. The study includes two main protocols: POS-ARI-PC AUDIT, which records and benchmarks approximately 2,000 anonymous patient cases annually in primary care, and POS-ARI-PC CORE, a non-randomized prospective observational study examining patient sampling, microbiology, and outcomes over 28 days. Both protocols cover patients presenting with symptoms of lower or upper respiratory tract infections or suspected COVID-19, influenza, or RSV. An embedded observational study (POS-ARI-PC-001) focuses on respiratory infections in older adults and those with long-term health conditions. Participants provide consent and have combined throat/nose swabs collected at baseline. They report daily symptoms for 14 days via online or paper diaries, with possible telephone follow-up for diary completion. Medical records are reviewed after 28 days to collect consultation and hospital referral data. Researchers monitor initial diagnosis, illness severity, medication use, test results, and recovery progress. Some participants may join an optional qualitative study exploring experiences with ARI care. Overall participation lasts 28 days, enabling detailed assessment of ARI in primary care.

Researchers are evaluating a new classification system for obstructive sleep apnea (OSA) in adults who have recently been diagnosed with this condition. The study aims to monitor long-term improvements both objectively and subjectively in patients with OSA. It focuses on patients who have a diagnosis confirmed by sleep studies and tracks changes in symptoms and cardiovascular measures over time. The study does not involve experimental treatments but observes participants over a period of up to 36 months. During this time, the classification system is applied, and patients are followed to assess changes related to sleepiness and blood pressure. The study is prospective and observational, meaning it follows patients forward in time without assigning specific treatments. Participants will be assessed at enrollment and monitored throughout the observation period. Key measurements include changes in daytime sleepiness using the Epworth Sleepiness Scale and changes in office systolic blood pressure. The study collects data to understand how the new classification relates to patient outcomes over three years, ensuring safety and adherence through regular follow-up visits and evaluations.

Researchers are studying STXBP1-related disorders (STXBP1-RD), rare genetic neurodevelopmental conditions caused by changes in the STXBP1 gene. These disorders often result in developmental delays, intellectual disabilities, seizures, behavioral problems, and movement disorders, with a wide range of symptoms and severity. There is currently no cure, and treatments mainly focus on managing symptoms. The study aims to better understand the disease's natural history, identify important clinical outcomes, and find reliable measures and biomarkers to support future clinical trials involving new targeted therapies. The study is organized by a European consortium and includes two phases: a 12-month Pilot Natural History Study (pNHS) followed by a 4-year Extension Natural History Study (eNHS). Data will be collected through a REDCap-based registry that includes retrospective and prospective information on patient demographics, genetics, and clinical features. The pilot phase will evaluate how well outcome measures reflect differences in disease severity and changes over time, as well as assess the burden of participation for patients and caregivers. Participants who complete the pilot phase may continue into the extension phase. Participants will be followed over time with detailed clinical assessments to track changes in their condition. Researchers will gather information from patients, caregivers, and clinical evaluations to understand disease progression and identify meaningful endpoints for future trials. The study also aims to assess the impact of STXBP1-RD on quality of life and unmet needs. Overall, this research will help prepare for clinical trials of new treatments by providing a comprehensive understanding of STXBP1-RD and relevant ways to measure outcomes.

Researchers are evaluating a phase 1/2 open-label study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical effects of an oral drug called Enzomenib (DSP-5336) in patients with acute leukemia, including relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), ambiguous lineage acute leukemia, and in certain sites, high-risk myelodysplastic syndromes (MDS) or relapsed multiple myeloma (MM). The study also examines Enzomenib combined with standard AML treatments such as venetoclax plus azacitidine and the intensive chemotherapy 7+3 regimen in patients newly diagnosed with AML who have specific genetic mutations (MLL rearrangement or NPM1 mutation). Participants receive oral Enzomenib either alone or combined with other drugs: venetoclax and azacitidine for a nonintensive treatment group, gilteritinib for a certain relapsed AML group, or intensive chemotherapy with cytarabine and daunorubicin (7+3) for newly diagnosed AML patients. The study includes dose escalation and expansion phases to determine recommended doses for phase 2. Treatment schedules and doses are adjusted based on response and safety, with some patients enrolled in specialized cohorts according to their genetic markers. Throughout the study, participants undergo regular assessments including clinical exams, laboratory tests, bone marrow samples for genetic analysis, and monitoring for adverse events. Researchers measure safety outcomes such as adverse and serious adverse events, determine optimal dosing for phase 2, and evaluate treatment effectiveness by tracking complete response rates. Safety is monitored up to 30 days after the last dose, with dose recommendations made within four months of treatment start and response assessed around six months. The total participation time varies based on individual treatment and study phase.