Liestal

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.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are investigating circulating tumor cells (CTCs) and clusters of CTCs in various types and stages of cancer. This observational study aims to understand the biology and role of CTCs as biomarkers and to identify important signaling networks active in these cells. The study includes adult cancer patients with histologically confirmed solid tumors, excluding precancerous lesions and blood cancers. Participants will have blood samples taken at multiple time points during their disease progression. Blood samples include three tubes of 7.5 ml each for CTC isolation and analysis, which may involve molecular studies, cell culture, and drug screening. Additionally, if tumor resection occurs, samples from tumor draining vessels will be collected for similar analyses. Throughout the study, researchers will monitor overall survival and changes in the number of isolated CTCs, with follow-up potentially lasting up to 20 years. Participants will undergo regular blood collections and assessments to evaluate CTC characteristics and their relation to disease progression and outcomes. This long-term observation helps understand the significance of CTCs in cancer prognosis and treatment.

This research investigates the best approach for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a condition where small blood clots block tiny arteries in the lungs. The study aims to clarify whether SSPE truly requires anticoagulant treatment or if careful monitoring without medication is a safe option. Currently, many patients receive anticoagulants, which can increase bleeding risk, but some evidence suggests that avoiding these drugs might be safe in selected patients without other complications. Participants are randomly assigned to receive either the anticoagulant drug rivaroxaban or a placebo, allowing comparison between clinical surveillance without anticoagulation and standard anticoagulation treatment. This phase 4, multicenter trial evaluates outcomes over a 90-day period following randomization. During the study, researchers monitor participants for recurrent venous thromboembolism and assess safety outcomes related to bleeding. Participants provide informed consent and are followed closely to observe any clots returning or adverse events. The total follow-up is at least 90 days to determine the efficacy and safety of withholding anticoagulation in this specific patient group.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating the effectiveness of first-line treatments for women with HER2-expressing, mismatch repair proficient (pMMR), primary advanced or recurrent endometrial cancer. This Phase III study compares two experimental combinations—trastuzumab deruxtecan (T-DXd) plus rilvegostomig and T-DXd plus pembrolizumab—against standard chemotherapy with carboplatin, paclitaxel, and pembrolizumab. The main goal is to measure progression-free survival, which is the length of time participants live without their cancer worsening, assessed up to about 45 months. Participants will be randomly assigned to one of three groups: Arm A receives trastuzumab deruxtecan combined with rilvegostomig, Arm B receives trastuzumab deruxtecan combined with pembrolizumab, and Arm C receives the standard chemotherapy combination with pembrolizumab. All treatments are given by intravenous infusion. The study is open-label and sponsor-blinded, meaning that participants and investigators know the treatments but the sponsor’s assessment is blinded. Throughout the study, participants will undergo regular assessments including tumor evaluations to monitor cancer progression. Researchers will track progression-free survival as the primary outcome measure. Safety and organ function will be monitored with tests such as left ventricular ejection fraction measurements and blood tests. The total study duration includes treatment and follow-up until progression or death, with evaluations conducted for up to approximately 45 months.

Researchers are evaluating whether digital voice analysis can identify measurable changes in audio signals that relate to frailty and emotional distress in patients, especially those with cancer. Frailty is common in older adults and increases risks such as falls, disability, hospitalization, and death. Early detection of frailty and distress can improve patient care and treatment planning. This study aims to analyze changes over time by recording voice samples and clinical data multiple times from the same patients, allowing comparison of voice features with wellbeing changes. The study collects speech samples using a tablet with an app that records synchronized audio and video while patients describe freely chosen images. Each session involves describing two to four images with several sentences. Voice parameters like frequency, jitter, shimmer, and others will be extracted and analyzed alongside frailty assessments (G8 questionnaire) and distress measures (Distress Thermometer). Machine learning methods may be used to identify key voice features linked to frailty and distress. Participants will be adults with active cancer who can speak, read, and understand German. They will undergo repeated voice recordings and complete questionnaires about frailty and distress over a 16-week period. Researchers will monitor changes in various voice characteristics, verbal fluency, and word timing as primary outcomes. The study also includes clinical assessments and safety monitoring to evaluate the feasibility of using digital voice samples as indicators of patient wellbeing.

Researchers are studying the long-term outcomes and adherence of the Inspire UAS System in patients with obstructive sleep apnea (OSA). This registry aims to collect information about patients' experiences and device use over time through their routine clinical care without requiring additional interventions or tests. Participants will have the Inspire UAS System implanted, a permanent device consisting of three components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. Patients also receive a remote control to activate the therapy. The study follows patients as they use the device during their standard care visits. Throughout the study, data such as the Apnea Hypopnea Index (AHI) and Epworth Sleepiness Scale (ESS) will be collected at baseline and follow-up visits when available. These measures help assess sleep apnea severity and daytime sleepiness. The study relies on routine clinical evaluations and does not mandate extra testing. Participants are monitored over time to understand device use and adherence.

Prostate cancer is a common cancer in men and a leading cause of cancer deaths in Europe. For men with localized prostate cancer who have a life expectancy over 10 years, radical prostatectomy is the standard treatment to improve survival. This research evaluates whether removing more lymph nodes in the pelvis, called extended pelvic lymph node dissection (ePLND), during surgery offers additional benefit by better staging the cancer and possibly removing hidden cancer cells, compared to not removing these lymph nodes. The study focuses on men with high-risk prostate cancer and negative PSMA-PET scans for metastasis. The study compares two groups of men undergoing radical prostatectomy: one group will receive extended pelvic lymph node dissection along with surgery, and the other group will have surgery without lymph node removal. Extended lymph node removal involves taking out more nodes to improve detection of cancer spread, but it may increase surgery time and complications slightly. The study is a multicenter, randomized Phase III trial. Participants will be monitored through prostate-specific antigen (PSA) tests three months after surgery to check for cancer persistence and followed for up to 24 months to observe biochemical recurrence-free survival. Researchers will assess cancer staging, treatment outcomes, and safety. The study includes regular evaluations and close follow-up to understand if extended lymph node removal improves long-term outcomes for men with high-risk prostate cancer.

Researchers are evaluating the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold in patients with coronary artery disease. This post-market study aims to assess the scaffold's performance in treating new coronary lesions in patients who have evidence of myocardial ischemia and are suitable candidates for angioplasty and stenting. The study focuses on patients who meet specific lesion criteria and are willing to comply with follow-up evaluations. Participants will receive treatment with the Fantom scaffold for de novo coronary lesions that meet detailed baseline criteria, including lesion size, vessel diameter, and absence of certain complications. The scaffold is designed to be placed in native coronary arteries with stenosis of 50% or more but less than 100%. The study includes only lesions that can be covered by a single scaffold and excludes lesions with severe complications or unsuitable vessel characteristics. During the study, participants will undergo follow-up evaluations to monitor the target lesion failure over 12 months. Researchers will assess safety and effectiveness by tracking clinical outcomes and complications related to the treated coronary lesions. The study involves ongoing monitoring to ensure patient safety and adherence to the protocol throughout the follow-up period.