Jonkoping

Researchers are investigating new treatments for locally advanced or metastatic urothelial cancer UC, a type of bladder cancer that has spread or cannot be removed by surgery or radiation. This trial evaluates whether sacituzumab tirumotecan sac-TMT, an experimental medicine, can help people with UC who have already been treated with specific therapies live longer compared to those who receive certain non-platinum chemotherapy options. The study is a Phase 3 randomized trial comparing sac-TMT with chemotherapy drugs selected by the investigator. Participants are assigned to one of two groups one receives sacituzumab tirumotecan at a dose of 4 mgkg every two weeks by intravenous infusion until the disease worsens or side effects become unacceptable. The other group receives one of three chemotherapy drugspaclitaxel, docetaxel, or vinflunineby intravenous infusion every three weeks, also until disease progression or unacceptable toxicity. Rescue medications may be given as needed to manage side effects according to approved guidelines. During the study, participants undergo assessments of overall survival up to about 40 months, along with other measures such as progression-free survival, response rates, duration of response, and quality of life evaluations using questionnaires. Safety is monitored by recording adverse events and treatment discontinuations. The total study participation may last several years, with regular evaluations to understand the effects and tolerability of the treatments.

Researchers are investigating ways to personalize treatment for patients with head and neck squamous cell carcinoma HNSCC, especially those with advanced disease who face a higher risk of treatment failure. This phase III study compares two radiotherapy approaches for patients intended for curative treatment the standard radiotherapy and a hyperfractionated radiotherapy HFX-RT with a higher total radiation dose. The study also aims to improve prognostic and predictive methods by including exploratory analyses such as MRI to evaluate tumor hypoxia, gene profiling, immune profiling, and imaging texture analyses during treatment and follow-up. Participants will be randomly assigned to either standard radiotherapy, which delivers 68.0 Gy in daily fractions of 2.0 Gy, or to hyperfractionated radiotherapy, which delivers 83.0 Gy in smaller doses twice daily 1.22 Gy per fraction over five days per week. The doses vary depending on the tumor volume and lymph node involvement. Patients with lower-risk tumors not eligible for randomization may still participate in the translational research parts of the study. During the study, participants will be closely monitored with regular follow-up visits every three months for two years, then every six months up to five years, focusing on local tumor control. Researchers will collect imaging data, conduct gene and protein analyses, and assess tumor response. The study evaluates treatment effects and tumor behavior over time to better understand and improve outcomes for head and neck cancer patients.

Researchers are evaluating a behavioural intervention called Light, activity and sleep in my daily life LAS aimed at improving quality of life for community-dwelling older adults aged 70 and over. The study focuses on addressing challenges related to circadian rhythm sleep disorders, poor sleep, reduced physical activity, and time spent indoors, which affect wellbeing in this population. The intervention targets light-related behaviour, outdoor walking, and sleep routines to promote active ageing and independence. The LAS intervention is delivered as a 9-week web-based course with nine modules covering electric lighting, daylight, outdoor physical activity, and sleep. Participants also receive a test kit with items like light bulbs, a sleep mask, and a sleep diary to support engagement and experimentation. The course includes one introductory physical meeting and three additional meetings held at a senior citizen meeting point. All participants receive the same noninvasive behavioural education and support. Participants complete questionnaires, interviews, and wear accelerometers to track activity and rest patterns before and after the course, with follow-ups at 3, 6, and 10 months after baseline. Outcomes measured include usability of the intervention, mood, sleep quality, behavioural skills, quality of life, physical activity, sedentary behaviour, and step counts. The study also explores factors that help or hinder daytime outdoor walking. Results will guide improvements for future delivery within municipal health promotion services.

Researchers are evaluating the safety and effectiveness of Verapamil in preserving residual insulin-producing beta cell function in children aged 4 to 9.99 years with recent onset Type 1 diabetes. This Phase III trial focuses on how Verapamil impacts clinical outcomes such as blood glucose control and insulin requirements, addressing a critical need to improve treatment and quality of life for young patients with this serious condition. The trial has two parts Part A involves 6 children receiving open-label Verapamil at doses of 3-6 mgkg per day divided into two oral doses for 12 months, primarily to assess safety. Part B will enroll 30 children randomized equally to receive either Verapamil or placebo twice daily for 12 months under double-blind conditions. Evaluations include mixed Meal Tolerance Tests MMTT and clinical measures like insulin dose, HbA1c, and continuous glucose monitoring over 24 months. Participants undergo baseline assessments including ECG, physical exams, and MMTT. Follow-ups occur at 12 and 24 months to monitor beta cell function, blood sugar control, insulin use, and safety events. The study carefully tracks treatment effects and tolerability, with the total participation duration spanning two years. This approach aims to identify if Verapamil can help maintain insulin secretion with minimal risks in young children newly diagnosed with Type 1 diabetes.

Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.

This observational study aims to describe the use of teclistamab and talquetamab in treating patients with relapsed or refractory multiple myeloma RRMM outside of clinical trial settings. It collects real-world data to better understand how these treatments are used and their outcomes in typical healthcare environments. The study enrolls participants who have received at least one dose of teclistamab or talquetamab outside clinical trials during specified time periods from before December 2022 through December 2025. No study interventions are administered instead, researchers analyze existing medical records to document treatment details and patient experiences with these therapies. Participants medical records are reviewed to capture baseline characteristics, response rates, time to response, duration of response, survival outcomes, safety management, and treatment use up to 40 months. The study focuses on collecting comprehensive retrospective data without requiring active treatment or additional procedures, providing insight into real-world treatment patterns and outcomes for RRMM patients.

Researchers are investigating the use of adjuvant CDK46 inhibitors combined with endocrine therapy in older breast cancer patients aged 70 years and above. This study focuses on the specific challenges faced by this population, including comorbidities that may increase the risk of treatment-related toxicities and affect quality of life. Due to limited representation of older patients in previous trials, this study aims to better understand the benefits and risks of such treatment in this age group and the role of geriatric assessments to guide therapy. Participants will undergo geriatric screening using tools such as the Geriatric 8 G8 and Vulnerable Elders Survey-13 VES-13 to assess frailty before starting adjuvant CDK46 inhibitor therapy alongside endocrine treatment. The study will examine multiple outcomes including treatment side effects, dose intensity, treatment discontinuation, quality of life, hospitalization, cancer recurrence, and survival. These measures will be collected over several years with follow-ups at various intervals, up to 10 years for some outcomes. Throughout the study, participants will complete questionnaires assessing frailty and quality of life at baseline and at multiple points after starting treatment. Adverse events, hospitalizations, dose adjustments, and treatment discontinuation will be monitored regularly up to six months after ending CDK46 inhibitor therapy. Long-term outcomes such as breast cancer recurrence and survival will be tracked at 3, 5, and 10 years. This approach aims to provide a thorough evaluation of how geriatric screening relates to treatment effects and long-term health in this patient group.

Researchers are evaluating whether a shorter period of immunotherapy after radical surgery is as effective as the standard longer treatment for patients with high-risk malignant skin melanoma. This study focuses on people aged 18 and older who have undergone surgery for stage IIb-c, III, or IV melanoma. The goal is to see if six months of immunotherapy can prevent cancer recurrence as well as the current 12-month treatment, potentially reducing side effects, hospital visits, and healthcare costs. The study is a randomized phase 3 trial conducted internationally with patients followed for up to five years. Participants will receive immunotherapy drugs, currently nivolumab or pembrolizumab, given intravenously. They are randomly assigned to either six months experimental group or 12 months standard group of treatment. Patients who had immunotherapy before surgery neoadjuvant treatment can also join, with their pre-surgery treatment time added to the post-surgery treatment. Medical exams and imaging scans CT or PET-CT are done at the start, six months, and 36 months, along with regular check-ups over three years. If cancer returns, additional tests and treatments are planned based on medical team decisions. During the study, participants will have scheduled visits for physical exams, blood tests, and scans to monitor their health and detect any recurrence. Researchers will measure relapse-free survival and distant metastatic-free survival at two years as primary outcomes, with overall survival and health economic effects also assessed over five years. Safety monitoring includes standard care practices and follow-up for up to five years. The study aims to confirm if shorter immunotherapy duration maintains the same outcomes while benefiting patients and healthcare systems.

Researchers are studying metastatic breast cancer in a program aiming to recruit 1300 patients from hospitals across Europe. Eligible participants are adults aged 18 or older, male or female, with a recent diagnosis of metastatic or locally advanced breast cancer or disease relapse who have not received more than one type of treatment for metastases. The goal is to better understand genetic changes in metastatic breast cancer and discover how tumors respond or resist therapy to eventually identify the most suitable treatment for each patient. The study is sponsored by the Jules Bordet Institute and focuses on molecular analysis of cancer samples. Participants will undergo a biopsy of a metastatic lesion either at program entry or up to six months before inclusion, and a sample of the primary tumor must be available. Blood, serum, and plasma samples will also be collected. These samples will be analyzed centrally, and any unused samples will be stored in a bio-repository for future research. The study offers the possibility for patients with certain genetic changes to join related clinical trials if available and approved in their country. Throughout the study, participants provide blood samples at screening and regular intervals during follow-up. Researchers will evaluate genetic alterations, identify exceptional responders and rapid progressors, and assess patient prognosis over up to 10 years. The study will also monitor the feasibility of molecular screening and correlate molecular findings with standard measures of treatment response. The total study duration extends to March 2031, with primary outcome review planned one year after recruitment ends.

Researchers are evaluating optimized pharmacologic treatments for patients with Takotsubo Syndrome, a condition often referred to as broken heart syndrome. This large randomized registry clinical trial aims to include 1000 participants registered in SWEDEHEART to better document effective treatments, as current data from large patient groups are lacking. The trial is a Phase 4 study sponsored by Vastra Gotaland Region and is designed as an open-label, multinational, multicenter trial. Participants are randomly assigned to different treatment groups. One group receives an adenosine infusion for 3 hours followed by oral dipyridamole twice daily until left ventricular function normalizes or up to about one month. Another group receives usual care per European Society of Cardiology recommendations. A separate randomization compares oral apixaban twice daily until normalization of heart function or about one month versus no anticoagulant therapy. The study monitors heart function with echocardiographic assessments at 48-96 hours and possibly later. During the study, participants undergo regular heart ultrasounds to assess wall motion and ejection fraction, along with monitoring for events such as death, cardiac arrest, heart failure, thromboembolic events, and bleeding. The trial collects data up to 30 days after treatment begins. Researchers also track heart rhythm problems and use standardized scoring to evaluate heart muscle movement. Safety and treatment outcomes are closely observed throughout the study period, which lasts until December 2028.