Bremerhaven

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are investigating the real-world use, effectiveness, quality of life impact, safety, and tolerability of the combination of encorafenib and binimetinib in patients with unresectable advanced or metastatic melanoma that has a specific BRAF V600 mutation. This prospective, longitudinal, non-interventional study focuses on patients in Germany, Austria, and Switzerland who receive these drugs after they became commercially available. The study includes patients receiving first or second line treatment, particularly after prior checkpoint inhibitor therapy. The study observes patients treated with encorafenib plus binimetinib according to approved prescribing guidelines (Summary of Product Characteristics). Patients may have started treatment within six months before joining the study or plan to start soon. No experimental interventions are given; instead, the study collects real-life treatment data under routine clinical care in multiple centers across the three countries. Participants will be followed to gather information on progression-free survival at 12 months after starting treatment. Data collected include safety, tolerability, quality of life, and treatment patterns. The study documents patient outcomes and treatment experiences in a naturalistic setting without altering standard care. Participation duration depends on treatment and follow-up schedules determined by routine clinical practice and study timelines.

Researchers are evaluating the clinical safety and effectiveness of the DERIVO4heal4 Embolisation Device in treating intracranial aneurysms. This prospective, single-arm, multicenter, open-label study is conducted in Germany across approximately 15 sites. The study aims to assess mid- and long-term clinical and angiographic outcomes, focusing on potential risks and updating the device's clinical evaluation to ensure its safety and performance after market approval. Participants will receive flow diversion therapy using the DERIVO4heal4 Embolisation Device to treat their intracranial aneurysm. The study plans to enroll up to 158 patients over 36 months, followed by a 12-month observation period. The device will be implanted as part of standard clinical routine, and treatment success, safety, and technical performance will be systematically recorded. During the study, patients will have scheduled follow-ups to monitor clinical progress and safety, with key outcome assessments at approximately 6 weeks, 6 months, and 12 months. Data on clinical and safety endpoints will be collected and validated using electronic case report forms and monitored for accuracy. Personal data will be securely handled according to regulations, and study results will be shared with ethics committees and may be published with investigator agreement.

Septic shock is a severe and life-threatening condition caused by a dysregulated response to infection leading to organ failure and high mortality. This trial investigates whether adding Therapeutic Plasma Exchange (TPE) early in treatment can reduce the harmful host response and improve outcomes in patients with early septic shock. The study is a randomized, prospective, multicenter, open-label, controlled trial designed to explore this promising adjunctive therapy in a patient group with very high mortality. Participants will receive TPE treatment initiated within 6 hours after randomization, lasting about 120 to 180 minutes. If patients remain dependent on vasopressors at a certain dose 24 hours after the first TPE, a second plasma exchange may be performed. Anticoagulants such as unfractionated heparin or citrate will be used during the procedure, and plasma replacement will be carefully adjusted to each patient's total plasma volume for consistency. Throughout the study, researchers will monitor participants for mortality up to 28 days after randomization as the primary outcome. The trial includes detailed assessments and ongoing clinical monitoring to evaluate the effect of TPE as an additional treatment alongside standard care. The total participation time includes early treatment and follow-up to measure survival outcomes and safety in this critically ill population.

Researchers are investigating treatments for triple-negative breast cancer (TNBC), a type of breast cancer known for its aggressive nature, poor prognosis, and diverse molecular characteristics. This study focuses on patients with early-stage, lower-risk TNBC, particularly those with stage I-II node-negative disease, who generally have better outcomes but still face significant clinical challenges. The trial aims to compare the effects of sacituzumab govitecan alone versus sacituzumab govitecan combined with pembrolizumab in this patient group, seeking to improve treatment responses and survival rates. Participants will receive sacituzumab govitecan at a dose of 10 mg/kg administered twice on days 1 and 8 within a 21-day cycle. Some participants will also receive pembrolizumab at 200 mg every three weeks. The study evaluates treatment durations between 12 and 18 weeks in the neoadjuvant (pre-surgery) setting. The purpose is to assess whether these regimens can produce comparable pathological complete remission rates with a better safety profile compared to standard chemotherapy. The combination with pembrolizumab is explored based on promising results in more advanced TNBC stages. Throughout the study, participants will undergo various assessments including imaging, pathology reviews, and laboratory tests to monitor tumor response and overall health. The primary outcomes measured are pathological complete remission at surgery and invasive disease-free survival rate after three years. Safety and tolerability will also be closely observed. Participants must comply with treatment schedules and follow-ups, providing consent and cooperating with all protocol requirements during the study period.

Researchers are studying pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under real-world conditions.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.

Researchers are evaluating the effectiveness and safety of using the self-expandable CREDOae Heal Stent for permanent stenting in patients with acute ischemic stroke caused by large vessel occlusion. This treatment is studied after unsuccessful attempts to reopen the blocked vessel using thrombectomy. The study focuses on patients who have persistent vascular occlusion due to severe intracranial artery narrowing and aims to improve blood flow in the brain. The intervention involves rescue stenting with the CREDOae Heal Stent combined with the NeuroSpeed PTA Balloon Catheter. This device-based treatment is applied after at least one failed mechanical thrombectomy attempt using devices like stent retrievers or direct aspiration. The procedure targets arteries in either the anterior or posterior brain circulation and is considered suitable by the treating physician based on the patient's condition. Participants will be monitored for success of vessel reopening immediately after treatment and assessed for their clinical outcome around 90 days later, focusing on their level of disability. The study measures include technical success of the procedure and functional recovery using standard scales. Safety and efficacy will be closely observed, with eligibility including adults over 18 years with specific stroke characteristics and symptom onset within 24 hours before treatment.

Researchers are evaluating the outcomes, late side effects, and cosmetic results of a single-session very accelerated partial breast irradiation as a local treatment after surgery for early stage breast cancer. This approach is being studied as a phase II multicenter trial to confirm safety and effectiveness based on previous studies that showed shorter treatment times with low side effects using fewer radiation sessions. The treatment involves one single fraction of accelerated partial breast brachytherapy delivered through an interstitial multicatheter technique. This differs from standard treatments that typically require 7-8 sessions over 4-5 days or shorter regimens of 3-4 fractions over 2 days. The new approach aims to safely reduce the total treatment time to one session. Participants will be monitored from three months after treatment through five years to measure the incidence of late side effects of grade 2 or higher. Researchers will assess clinical outcomes, side effects, and cosmetic results over this follow-up period to evaluate the long-term safety and effectiveness of this single-fraction radiation therapy.

Researchers are studying the use of venetoclax in people with chronic lymphocytic leukemia (CLL) to understand how effective it is and to assess the costs and patient-reported outcomes when used in real-life medical settings. The study looks at venetoclax given alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib, based on doctors' decisions and local treatment guidelines. Participants receive venetoclax therapy as prescribed by their physician, which may include the drug alone or along with one of the mentioned combination treatments. The study follows patients in Austria, Germany, and Switzerland, observing how the treatments are used in everyday practice without altering the prescribed therapy. During the study, participants are monitored for up to 12 months to measure the percentage who achieve the best overall response rate (ORR) to treatment. Researchers also collect data on health economics and patient experiences to better understand the impact of these therapies in routine care.