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Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.

Researchers are evaluating the effectiveness of two treatment combinations, 5-FU with nanoliposomal irinotecan (NALIRI) and 5-FU with nanoliposomal irinotecan plus oxaliplatin (NALIRINOX), for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) that has progressed after initial gemcitabine-based therapies. This phase 2 randomized study focuses on patients who are physically fit with good performance status (ECOG 0-1). The main goal is to measure how long patients live without disease progression after starting these treatments. Participants will be randomly assigned to one of two groups. The control group receives NALIRI with 5-FU and leucovorin, while the investigational group receives NALIRINOX, which adds oxaliplatin to the same combination. Dosing varies between groups: NALIRI is given at 70 mg/m² with 2400 mg/m² of 5-FU and 400 mg/m² of leucovorin, while NALIRINOX includes 50 mg/m² of nanoliposomal irinotecan, 2400 mg/m² of 5-FU, 400 mg/m² of leucovorin, and 60 mg/m² of oxaliplatin. The study assesses safety, side effects, tumor response via imaging and tumor markers, and overall survival alongside progression-free survival. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor size and response, blood tests to monitor safety and tumor markers, and evaluations of side effects using standard criteria. Researchers will track progression-free survival at day 85 from randomization as the primary outcome. The study also monitors overall survival and treatment tolerability. Participants must be monitored for safety throughout, with follow-up visits to assess long-term outcomes and treatment effects.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating a new treatment approach for colon cancer, focusing on patients with previously untreated T4N0 or Stage III mismatch repair proficient/microsatellite stable (MMRp/MSS) colon cancer. This study compares the combination of dostarlimab and CAPEOX chemotherapy (capecitabine plus oxaliplatin) given before surgery, called neoadjuvant therapy, against CAPEOX chemotherapy alone. The goal is to see if the combined treatment shows early signs of better effectiveness and to explore blood and tumor markers that might predict treatment response. The study involves two treatment groups: one receiving dostarlimab plus CAPEOX and the other receiving CAPEOX alone. Dostarlimab is a biological therapy administered alongside the chemotherapy drugs capecitabine and oxaliplatin. These treatments are given before surgery to remove the tumor. The study is open-label and randomized, meaning participants are assigned by chance to one of the two treatment options without masking. Participants undergo assessments up to approximately 18 weeks to measure major pathological response rates, which indicate how well the tumor responds to treatment. Safety is monitored throughout the study and up to about 105 weeks, including tracking adverse events, serious adverse events, immune-mediated adverse events, and any treatment discontinuations or deaths related to side effects. This long-term monitoring helps evaluate both the effectiveness and safety of the treatment approaches.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the clinical value of comprehensive genomic profiling (CGP) performed by local Belgian next-generation sequencing (NGS) laboratories in patients with metastatic or locally advanced solid tumors. This study, called BALLETT, aims to improve cancer patient care by broad molecular profiling and to demonstrate that broad molecular testing can be done in a decentralized, standardized way across nine Belgian laboratories. The study will enroll 936 patients from 13 hospitals and cancer centers over two years, focusing on detecting clinically significant genetic variants and guiding precision medicine treatment recommendations. Patients will undergo comprehensive genomic profiling using the Illumina TSO500 NGS panel, which analyzes 523 genes to identify single nucleotide variants, small insertions/deletions, copy number variations, and gene fusions, as well as tumor mutational burden and microsatellite instability status. The CGP testing and variant classification are standardized across participating laboratories. Results are reviewed weekly by a national molecular tumor board (MTB) consisting of oncologists, pathologists, molecular biologists, geneticists, and bioinformaticians, who provide therapy recommendations including targeted therapies, immunotherapies, clinical trials, or off-label drug use. Treating physicians decide on the final management, with reasons for not following recommendations recorded. Participants will be monitored throughout the study, which averages one year, to measure the number and types of clinically significant genetic variants and to describe the patient journey. The study also assesses clinical benefits by comparing progression-free survival on CGP-guided therapies versus prior treatments. Data management includes standardizing CGP data analysis, therapy recommendations, and reporting, and contributes to a Belgian genomic tumor database. Safety and compliance are monitored, and the study supports increasing access to innovative treatments and clinical trials in Belgium.

Central sleep apnea (CSA) is a condition where breathing stops or decreases during sleep due to reduced respiratory effort. This research aims to study the factors that influence treatment decisions and how well patients follow their treatment plans for CSA in Belgium. The study also seeks to better understand the clinical features and effects of CSA, especially given its link to daytime sleepiness and risks in heart failure patients. Participants will receive routine care as part of a registry; there is no experimental treatment involved. The study collects information on the treatments chosen for CSA and monitors patient compliance and outcomes over time. During the study, researchers will gather data through standard clinical assessments and sleep studies to evaluate treatment choices and patient adherence. The primary outcome is the treatment choice over a five-year period. Participants will be followed to observe how treatments affect their condition and overall health.

Researchers are evaluating whether taking a low daily dose of colchicine (0.5 mg) along with standard treatment reduces the number of cardiovascular events in patients with coronary artery disease who have undergone percutaneous coronary intervention (PCI). This phase III, randomized, double-blind, placebo-controlled trial aims to confirm the benefits of colchicine in preventing further heart-related issues and to identify patients at higher risk who might benefit most from this treatment. Participants will be randomly assigned to receive either colchicine 0.5 mg or a matching placebo once daily, in addition to their standard care. The study plans to enroll up to 2770 patients and will continue until 566 primary endpoint events occur. Follow-up includes an in-person visit at 1 month after randomization, then yearly visits aligned with standard care for treatment dispensing, compliance checks, questionnaires, and event assessments. Telephone visits will also occur every 6 months between on-site visits. During the study, researchers will monitor participants for serious cardiovascular events such as death, heart attacks, strokes, or additional heart procedures over a period of 44 months. Participants will undergo regular assessments including questionnaires and compliance monitoring. The study's primary outcome is the time until the first occurrence of the composite cardiovascular endpoint, with ongoing safety and effectiveness evaluations throughout the study period.

Researchers are investigating treatments for chronic knee pain caused by osteoarthritis (OA) or persistent pain following knee replacement surgery. This study focuses on patients with moderate to severe knee pain lasting more than 12 months that has not improved with standard treatments like physiotherapy, medication, and corticosteroid injections. The trial aims to compare the effects and cost-effectiveness of two types of radiofrequency (RF) treatments—cooled and conventional RF—against a sham procedure in reducing knee pain and improving function and quality of life. Participants will be randomly assigned to receive either conventional RF, cooled RF, or a sham procedure involving needle placement without active treatment. Conventional RF applies heat to the nerves around the knee to block pain signals, while cooled RF uses internal cooling to create a larger treatment area. The study includes a run-in period of 1 to 3 months to ensure conservative treatments are optimized before randomization. After treatment, patients will be followed for up to 2 years to observe long-term effects. During the study, researchers will assess knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) six months after treatment. Participants will undergo evaluations including clinical assessments, pain diaries, and imaging if needed. Safety and treatment adherence will be monitored throughout the trial. The overall study duration is approximately four years, involving multiple centers, with a total of 400 patients expected to participate.

Researchers are evaluating the effectiveness of differential target multiplexed spinal cord stimulation (DTM SCS) for treating chronic back and leg pain, specifically in patients with Failed Back Surgery Syndrome (FBSS) and Persistent Spinal Pain Syndrome Type 2. The study will also analyze differences in outcomes between patients using paddle/surgical leads versus those using percutaneous leads. Participants will receive spinal cord stimulation using the differential target multiplexed stimulation device. The study is observational and includes patients suitable for DTM SCS treatment as determined by their physician. There are no separate treatment groups described, but subgroup analysis will compare different lead types. Participants will be assessed for overall pain intensity using the Visual Analogue Scale (VAS) at baseline, then at 1 month, 6 months, and 12 months after the DTM stimulation. The study involves regular visits to monitor pain levels and treatment outcomes. Participants must comply with the study protocol, including attending scheduled visits and following instructions.