Vaasa

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had successful endoscopic removal of common bile duct stones. The study focuses on a combined outcome of death, major postoperative complications, or recurrent biliary disease within one year after randomization. The trial is designed as a randomized study involving elderly patients with specific age and health criteria. Participants are randomly assigned to either the laparoscopic cholecystectomy group or the wait-and-see group in equal numbers. The cholecystectomy procedure is performed during the same hospital stay or within two weeks after randomization. The study includes one planned interim safety analysis after 100 patients have been randomized, with the trial possibly ending early if significant differences in outcomes are detected between the two groups. During the study, researchers will monitor participants for death, major complications, or recurrent biliary events from the time of randomization up to one year. Safety and efficacy are carefully assessed to determine if the wait-and-see strategy is not worse than surgery. Participants' health status and outcomes will be tracked throughout the year following their enrollment in the trial.

This research aims to assess the impact of first-visit foam sclerotherapy on patients with venous leg ulcers. It compares this approach to the current standard scheduled treatment to determine which leads to faster ulcer healing. The study is based on prior data suggesting potential benefits of early foam sclerotherapy and includes patients with ulcers lasting between one month and one year. Participants are randomly assigned to either receive foam sclerotherapy at their first visit or to follow the scheduled treatment plan. Both groups also receive endothermal ablation and/or foam sclerotherapy during scheduled visits to treat problematic veins related to the ulcer. All participants use class 2 thigh-high compression stockings or the best tolerated compression therapy as part of their care. The treatments focus on insufficient truncal and distal veins. During the study, patients are monitored for up to one year to measure the time it takes for their ulcers to heal. Researchers use duplex ultrasonography to verify vein reflux and assess arterial circulation. Safety and healing progress are carefully tracked, with the primary outcome being the duration until ulcer healing. The total study plans to enroll 248 patients to ensure reliable results.

Researchers are evaluating the effectiveness of different smoking cessation methods combined with low-dose CT (LDCT) lung cancer screening in individuals aged 50 to 74 years who have a significant smoking history and continue to smoke. The study aims to compare how well these methods help people quit smoking, detect lung cancer at various stages, and improve lung cancer-specific survival. Participants are randomized into three groups to assess these outcomes. Participants are assigned to one of three groups: the first group receives LDCT screening along with a smoking cessation program delivered through a smartphone application; the second group receives LDCT screening combined with written materials to support smoking cessation; the third group uses the smartphone application for smoking cessation without LDCT screening. The study uses a prospective design to monitor outcomes across these groups. During the study, researchers track participants’ smoking cessation rates over three months, lung cancer detection, and survival related to lung cancer. Participants must have access to a smartphone and continue smoking to take part. The study involves monitoring how well participants follow the cessation programs and undergo screenings or receive written information, with the overall goal of improving lung cancer detection and helping smokers quit.

Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response. Objective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences. Design: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM. Primary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM. Secondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years. Inclusion Criteria: Patients must have histopathologically confirmed primary rectal adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR) after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment after considering the risk of recurrence. Exclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18, those not receiving neoadjuvant treatment, or those unable to provide informed consent are excluded. Diagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with clinical examination, laboratory tests, and imaging. Randomization: No randomization is performed. Follow-up: Patients are monitored every 3 months for the first 2 years, then every 6 months for 3 years. Monitoring replaces surgical intervention unless cancer recurs. Follow-up is part of standard care, with costs covered by the healthcare system. Safety: Incidence of local recurrence and success of resection post-recurrence are monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study termination at the center. Data Collection: Clinical data are entered into electronic case report forms (eCRFs) based on primary healthcare documentation and stored pseudonymized on the primary research center's server. Molecular and pseudonymized clinical data are collected securely for analysis. Sample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated to provide sufficient data for the primary and key secondary endpoints and to meet other study objectives accurately. Data Handling: Data handling adheres to privacy legislation, with information stored pseudonymously.

Researchers are investigating whether a simple home exercise program can help patients with advanced chronic kidney disease (CKD). The study also includes an observational group without the exercise program to examine the link between cardiovascular and kidney health, exercise capacity, and adverse outcomes. The research focuses on risks such as premature death, cardiovascular events, hospital visits, and kidney function decline, particularly in patients who are frail and elderly. Participants receive a single session with a registered physiotherapist who teaches them how to perform physical training exercises independently at home at least three times a week throughout the study. The study includes a controlled trial of this physical education program along with an observational follow-up to assess its effects. Researchers will track outcomes such as mortality, major cardiovascular or cerebrovascular events, emergency department visits, hospitalizations, need for dialysis, and walking capacity over multiple years. Throughout the study, patients will undergo evaluations including blood tests, X-rays, quality of life assessments, and exercise capacity measurements. The study will monitor compliance with the home exercise program and measure long-term health outcomes up to December 2031. This comprehensive approach aims to understand how frailty and physical activity affect health in advanced CKD and whether exercise can improve prognosis and quality of life.