Amsterdam

Researchers are evaluating the long-term outcomes of stopping endoscopic surveillance in patients with low-risk non-dysplastic Barrett's esophagus (NDBE). This study focuses on whether discontinuing surveillance increases the incidence of clinically apparent esophageal adenocarcinoma (EAC). It is a nationwide, prospective, single-arm observational study in the Netherlands, following patients for at least 10 years to assess the impact of the updated Dutch guideline, which recommends stopping surveillance in low-risk cases due to lack of evidence for survival benefit and cost-effectiveness. The intervention involves discontinuing endoscopic surveillance for eligible patients based on new guidelines. Eligible patients include those with Barrett's esophagus segments less than 5 cm, no history of dysplasia, and no family history of EAC. Patients will be followed in two cohorts: those with a history of surveillance at inclusion and those newly diagnosed. Data will be collected from national registries and medical records over the 10-year period without additional procedures or treatments imposed by the study. Participants provide informed consent for inclusion in the registry but are not required to undergo extra interventions. Researchers will collect data annually from national databases and patient files to monitor outcomes. The main measure is the incidence of clinically apparent EAC, defined as EAC causing death or requiring treatments beyond curative endoscopy. Safety and data protection are emphasized, and a data safety monitoring board will review results yearly according to predefined stopping rules.

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.

This research aims to evaluate how an individualized treatment plan affects traumatized parents and their young children aged 4 to 6 years old who have experienced domestic violence. The study focuses on reducing post-traumatic stress disorder (PTSD) symptoms in both parents and children, as well as improving parenting behaviors. The treatment plan is tailored according to a guidance document that helps therapists decide the best order of different therapies based on each family's needs, addressing the complex interactions between PTSD symptoms and parenting behavior. Participants will receive a combination of trauma therapies including Eye Movement Desensitization and Reprocessing (EMDR) therapy for both parent and child, and attachment-based therapy called NIKA for parents. NIKA consists of five weekly sessions where parents receive personalized feedback aimed at improving parenting behavior. EMDR therapy involves up to six sessions for the parent and child separately, where traumatic memories are processed with therapist support. The treatment is delivered over a trajectory determined by the guidance document, with weekly sessions throughout the study. Families will be involved for a minimum of 14 weeks and up to 25 weeks, with weekly assessments throughout this period. Researchers will measure changes in disrupted and sensitive parenting behaviors, as well as PTSD symptoms in both parent and child. These measurements will help understand how symptoms and behaviors develop and interact over time with treatment. The study includes regular monitoring and aims to assess whether starting treatment reduces disruptive parenting and PTSD symptoms compared to baseline behavior.

Researchers are investigating the effectiveness and cost-effectiveness of Attachment Based Family Therapy (ABFT) compared to Treatment As Usual (TAU) for young adults aged 18 to 25 who experience frequent suicidal thoughts. This mental health issue is a serious concern worldwide, especially in Belgium and the Netherlands, where suicide is a leading cause of death among young adults. Current treatments have limited success, and this study aims to see if ABFT, which focuses on improving family relationships, can better reduce suicidal thoughts and behaviors and support young adults and their families. The study is a randomized controlled trial involving 138 participants from multiple sites including hospitals, mental health centers, and private practices in Belgium and the Netherlands. Participants are assigned to either ABFT plus TAU or TAU alone. ABFT is a manualized therapy that strengthens parent-child attachment to create a secure support base, delivered in weekly sessions over about 16 weeks. TAU consists of existing standard treatments such as antidepressants, cognitive behavioral therapy, or dialectical behavior therapy, with limited family therapy. Parents or caregivers may be involved in both treatments. Participants will be assessed at baseline, immediately after treatment, and at 3, 6, and 12 months follow-up to measure changes in suicidality using questionnaires and therapist reports. Researchers will also evaluate cost-effectiveness, family functioning, depressive symptoms, and treatment adherence. The study aims to improve clinical guidelines and policymaking to enhance care for suicidal young adults and their families over a one-year period.

Researchers are investigating severe asthma by following patients who begin biological therapy and continue observation for three years. This study is part of the 3TR Consortium, a large European collaboration aiming to improve understanding of molecular pathways influencing treatment response, remission, and non-response in autoimmune and inflammatory diseases, including asthma. It focuses on how biological treatments affect severe asthma and seeks to identify biomarkers and immune mechanisms linked to treatment outcomes, including remission and non-response. Healthy individuals and patients with mild to moderate controlled asthma also participate as reference groups. Patients with severe asthma starting biological treatments are enrolled and followed through scheduled visits at baseline, 4 weeks, 16 weeks, 52 weeks, 2 years, and 3 years. At each visit, clinical and biological assessments are performed, including core and extended sampling packages, with additional visits allowed during asthma exacerbations. The study includes a sub-study in the Netherlands focusing on patients treated with Benralizumab, using advanced breath analysis and imaging techniques to understand airway changes and treatment response. Participants undergo extensive assessments including clinical exams, biomarker sampling, and imaging studies to evaluate asthma control, lung function, exacerbations, and steroid use. Researchers measure changes in asthma control scores, lung function, and absence of exacerbations over 1, 2, and 3 years. Data from healthy and mild/moderate asthma control groups provide important baseline comparisons. The study aims to identify immune activation patterns and biomarkers that predict or explain treatment response and remission in severe asthma.

Researchers are evaluating a new radioactive imaging agent called [18F]ACI-19626 to safely and reliably measure the accumulation of the pathological protein TDP-43 in the brain. TDP-43 is involved in rare forms of dementia such as frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). The study will include both healthy individuals and people suspected to have TDP-43 accumulation to compare protein levels and assess the tracer's ability to detect abnormalities. Participants will receive an intravenous injection of [18F]ACI-19626 and undergo a positron emission tomography (PET) scan to visualize TDP-43 deposits in the brain. The study consists of up to three parts, with up to 45 participants including healthy controls and people with TDP-43 proteinopathies. Some participants may have a second PET scan within one month to check the repeatability of the imaging results. During the study, participants will have multiple visits over a period of up to three months, including screening with physical and neurological exams, questionnaires, blood and urine tests, ECG, and MRI in some cases. Blood samples will be taken during the PET scan, and safety will be monitored with follow-up phone calls. Researchers will assess adverse events, vital signs, brain uptake of the tracer, and radiation exposure to evaluate safety and tracer performance.

Carcinoma of unknown primary origin (CUP) refers to a group of cancers where metastatic disease is present, but the original tumor is not found despite thorough diagnostic tests. This condition limits treatment options since the primary tumor, which guides therapy decisions, remains unidentified. The study aims to use a new PET-CT scan with a radiotracer called [18F]F-fluoro fibroblast activation protein inhibitor (F-FAPI) to detect the primary tumor in CUP patients. This is a prospective clinical study involving 50 patients aged 18 years and older who have already undergone standard diagnostic work-up including FDG PET-CT without identifying the primary tumor. Participants will undergo a one-time [18F]F-FAPI PET-CT scan at one of six study centers. The images will be centrally reviewed, and results along with recommendations for further tests or treatment will be shared with the treating physician. After six months, the PET-CT findings will be compared with patient follow-up data including clinical, radiological, and pathological outcomes. These results will be discussed in a multidisciplinary meeting to evaluate the clinical usefulness of the [18F]F-FAPI PET-CT scan for CUP patients. During the study, patients will have only this single PET-CT examination with [18F]F-FAPI. Researchers will monitor the detection rate of the primary tumor over two years. The main outcome measured is whether the primary tumor is identified by the scan. Safety and any impact on patient care will also be assessed through follow-up and clinical evaluations. The total duration of patient involvement includes the initial scan and a six-month follow-up for outcome comparison.

Researchers are evaluating a new scan called FAPI-PET/CT to detect metastases in patients with advanced gastric cancer. The study aims to find out how well this scan identifies metastases and whether it reduces the burden on patients compared to current methods. Key questions include how often the scan changes treatment plans, such as avoiding unnecessary surgeries or switching to palliative care, and how it affects the diagnostic process with additional biopsies or surgery adjustments. Participants will receive the intravenous drug [18F]-FAPI-74 one hour before undergoing the FAPI-PET/CT scan. This scan is done after initial staging with gastroscopy and a contrast-enhanced CT but before a staging laparoscopy. Based on the scan results, the medical team will decide the next steps, which may include biopsy confirmation of suspect lesions or performing diagnostic laparoscopy if the scan is negative. During the study, participants will have one additional scan lasting about two hours (excluding travel) and complete several questionnaires totaling around four hours. Researchers will track changes in treatment intent for about one year and monitor changes in diagnostic work-up immediately after clinical staging involving FAPI-PET/CT and other diagnostic procedures. Safety and treatment decisions will be closely followed throughout the study period.

Researchers are evaluating the use of [68Ga]Ga-FAPI-46 PET/CT imaging in patients with pancreatic or bile duct cancer to improve detection and monitoring of tumor lesions. The study focuses on three parts: determining the best timing and scan protocol, assessing repeatability of the scan results, and evaluating the accuracy of the scan in detecting cancer and monitoring chemotherapy response. Pancreaticobiliary cancers have a poor outlook, and better imaging methods could help guide treatment decisions and avoid unnecessary surgery. Participants will undergo one or two [68Ga]Ga-FAPI-46 PET/CT scans depending on the study part. In part A, patients have one scan with placement of two venous cannulas and one arterial cannula. In parts B and C, patients receive two scans each with venous cannula placement before scanning. The scans use a tracer targeting fibroblast activation protein to identify cancer tissue more accurately than conventional imaging. During the study, participants will have blood activity and plasma-to-blood ratio measurements of the tracer taken, along with semi-quantitative assessments of tracer uptake. Researchers will measure repeatability, diagnostic accuracy, and therapy response monitoring over a three-month period. The study includes safety monitoring and requires adherence to protocol procedures throughout participation.

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.