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Found 704 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the long-term outcomes of stopping endoscopic surveillance in patients with low-risk non-dysplastic Barretts esophagus NDBE. This observational study aims to determine whether discontinuing surveillance leads to an increase in clinically significant esophageal adenocarcinoma EAC, focusing on patients with Barretts esophagus less than 5 cm in length, no history of dysplasia, and no family history of EAC. The study is a nationwide, prospective, single-arm project in the Netherlands with a minimum follow-up duration of 10 years. In this study, endoscopic surveillance is discontinued following new Dutch guideline recommendations for eligible low-risk NDBE patients. Participants are then monitored through existing national registries and medical records without additional procedures or interventions. Two patient groups will be analyzed separately those with prior surveillance history and those newly diagnosed with NDBE at inclusion. Data collection involves pathology reports, national statistics, and cancer registries, with outcomes reviewed annually by a data safety monitoring board. Participants provide informed consent to be included in the registry, but no active involvement or changes to their care are required beyond standard practice. Researchers will track the incidence of clinically apparent EAC, defined by EAC-related death or EAC requiring palliative or non-curative treatments, over at least 10 years. Privacy protections and ethical standards are carefully maintained throughout the study to minimize risks and ensure confidentiality.
Actively Recruiting
Young adults aged 18 to 25 who experience frequent thoughts about killing themselves are the focus of this study, which evaluates the cost-effectiveness of Attachment Based Family Therapy ABFT compared to Treatment As Usual TAU. Suicide is a leading cause of death among young adults, and current treatments have limited success. This trial aims to determine if involving family through ABFT can better reduce suicidality and improve outcomes, informing clinical guidelines and care practices in Belgium and the Netherlands. Participants are randomly assigned to one of two groups the experimental group receives ABFT as an add-on to TAU, which includes treatments like antidepressants, CBT, or DBT, with weekly ABFT sessions lasting about 16 weeks. The control group receives TAU alone, allowing up to four sessions of systemic family therapy. ABFT focuses on strengthening parent-child attachment bonds to provide a supportive base for young adults, involving parents or caregivers actively in therapy. Throughout the study, suicidality is measured at baseline, immediately after intervention, and at follow-ups 3, 6, and 12 months post-intervention using tools like the Suicidal Ideation Questionnaire Junior. Researchers also assess depressive symptoms, family functioning, attachment, quality of life, and healthcare costs. The trial includes 138 participants across multiple sites, with double-blind randomized allocation. Safety, adherence, and cost-effectiveness are closely monitored during and after the treatment period.
Actively Recruiting
Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.
Actively Recruiting
Healthy Volunteer
3TR-ABC follows people with severe asthma from the day they start a biologic and keeps following them for three years. It is observational, meaning the study does not decide who gets which drug. Patients begin their biologic through normal clinical channels, according to whatever criteria apply in their country, and the study observes what happens next. The point is to work out why these expensive, highly targeted drugs transform life for some patients and do very little for others. The structure is a platform rather than a single trial. One shared core design sits underneath, and individual studies focused on specific biologics run on top of it, each free to add its own extra measurements while keeping the visit schedule and sampling aligned so results can be pooled. Only patients who have never had a biologic before are enrolled. They are assessed thoroughly at the start, then seen again at 4 weeks, 16 weeks, 52 weeks, and at the 2 and 3 year marks, with additional sampling whenever an exacerbation happens. Some sites collect a core package of samples, others an expanded one. Behind it all is the 3TR Consortium, a collaboration spanning 15 European countries and 69 partners, working across seven immune-driven diseases including asthma, COPD, Crohns disease, ulcerative colitis, multiple sclerosis, lupus, and rheumatoid arthritis. It is the largest immunology project the Innovative Medicines Initiative has funded. The asthma work sits in what the consortium calls work package 8, and its guiding questions are blunt ones what separates a good responder from a non-responder, and can severe asthma actually be pushed into remission rather than merely managed. Participants are sorted after the fact into three groups based on how they did remission, clinical response, and non-response. The blood, tissue, and breath samples collected before anyone started treatment are then compared across those groups, along with how each groups immune activity shifted over time. Healthy volunteers and people with mild or moderate controlled asthma go through the same baseline visit and serve as reference points, giving the researchers a sense of what these markers look like outside of severe disease. Samples feed into multi-omic analysis, which means examining genes, proteins, metabolites and more from the same person to map the biological pathways involved. The main target is a set of baseline markers that predict remission at one year. Remission here has a specific definition an ACQ-5 score below 1.5, lung function after bronchodilator either at or above 80% of predicted or improved by more than 10%, no exacerbations, and no maintenance steroid use across the previous twelve months. The same question is asked again at three years, alongside how marker profiles shift between those who reach remission and those who dont, how each individual response measure behaves, and how physician and patient ratings of treatment benefit compare with the consortiums own composite response measure. Exploratory work applies network and cluster analysis, discriminant methods such as PLSDA, daily FENO readings, and analysis of host and microbiome interaction to hunt for biomarker signatures nobody has identified yet. One cohort within the platform, AIR-BIO-OCT, focuses on patients taking benralizumab and goes a step further into the airway wall itself. Biologics are currently matched to patients through phenotyping that leans on clinical features, oral steroid use, and eosinophil counts in blood, sputum, or lavage fluid. What remains unclear is whether these drugs change airway remodeling, the structural thickening involving smooth muscle and extracellular matrix that tracks with how severe and how persistent the disease becomes. This substudy pairs exhaled breath analysis, using both GC-MS and electronic nose technology to read volatile organic compounds, with omics and with optical coherence tomography imaging, including a polarization-sensitive form of OCT. Endobronchial biopsies alongside the imaging are used to establish whether smooth muscle and matrix actually decrease after six months to a year on benralizumab. The broader hope is a minimally invasive breath-based signature that could flag likely responders before treatment ever starts.
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Healthy Volunteer
Researchers are evaluating a new imaging method to detect the accumulation of a protein called TDP-43, which is linked to rare brain diseases like frontotemporal dementia FTD and amyotrophic lateral sclerosis ALS. The study aims to see if the new PET tracer, called 18FACI-19626, is safe when injected and if it can reliably show abnormal TDP-43 in the brain. The study includes both healthy people and those suspected of having TDP-43 protein buildup to compare differences. The study involves up to 45 participants split into groups healthy controls, symptomatic gene mutation carriers with FTD, and patients with other TDP-43 related diseases. Participants receive an intravenous injection of 18FACI-19626 followed by a PET scan to track the tracers brain uptake. Some participants may have a second PET scan within a month to check if the results are consistent. The study lasts up to 3 months, including screening, scanning, and follow-up. During the study, participants will undergo physical and neurological exams, questionnaires, blood and urine tests, ECGs, and sometimes MRI scans to confirm eligibility and health status. After the PET scan, blood samples are taken, and participants receive a phone call 2 to 4 days later to monitor any side effects. The main measurements include safety assessments, brain uptake of the tracer, and how well the scans can quantify TDP-43. The study also evaluates radiation exposure and tracer consistency between scans.
Actively Recruiting
Carcinoma of unknown primary origin CUP is a group of cancers where metastatic disease is present but the original tumor cannot be found despite extensive tests. This condition limits treatment options since therapies often target known primary tumors. Researchers are evaluating whether a new imaging test called 18FF-fluoro fibroblast activation protein inhibitor F-FAPI PET-CT can detect the primary tumor in patients diagnosed with CUP after standard diagnostic scans including FDG PET-CT. This multi-center, prospective clinical study involves 50 adult patients with CUP to better understand the usefulness of this new scan method. Each participant will undergo a single 18FF-FAPI PET-CT scan at one of the six study centers. Images from this scan will be centrally reviewed and shared with the treating doctor, who may recommend further tests or treatments based on the findings. After six months, results from the F-FAPI PET-CT will be compared with clinical, radiological, and pathological follow-up data. A multidisciplinary panel will then review all information to decide how valuable the 18FF-FAPI PET-CT is for identifying the primary tumor in CUP patients. Participants will be involved in one main scanning visit and followed for six months through routine clinical assessments. The study team will monitor detection of the primary tumor using the new scan as the main outcome, and also assess the tests accuracy measures like sensitivity and specificity. Participation requires being able to undergo the scan and complete follow-up, with the entire process lasting about two years for outcome measurement. This study is sponsored by Erasmus Medical Center.
Actively Recruiting
Researchers are studying a new type of scan called FAPI-PETCT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PETCT scan, where a small amount of 18F-FAPI-74 is given intravenously about 60 minutes before a PETCT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.
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Researchers are investigating changes in the uptake of a special imaging tracer called 18FF-AraG to better understand how activated T-cells behave during anti-PD-1 immunotherapy in patients with advanced non-small cell lung cancer NSCLC. This study aims to improve the assessment of the tumor microenvironment by using PET scans to detect immune activity, helping to identify areas in tumors with high concentrations of activated T-cells. Participants in this trial will receive three 18FF-AraG PET scans at the start of treatment, at two weeks, and at six weeks during anti-PD-1 immunotherapy. These scans are used to measure the amount of activated T-cells in tumor lesions and lymphoid organs over time, providing valuable information about the immune response to treatment. During the study, researchers will evaluate changes in tracer uptake and correlate these with tumor response at twelve weeks. Participants will provide either a fresh or archival biopsy, and their health status will be monitored through imaging and clinical assessments. The study will continue through twelve weeks to assess immune activity and treatment effects, with safety and performance status monitored throughout the trial period.
Actively Recruiting
Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.
Actively Recruiting
Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.
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