Wesel

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating the real-world effectiveness of asciminib in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This observational study compares patients who are newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor TKI to those treated with other TKIs. The study aims to assess tolerability, safety, and molecular response outcomes in routine clinical care. Participants are grouped into cohorts based on their treatment those receiving asciminib, those newly diagnosed treated with imatinib, and those newly diagnosed treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by physicians prior to enrollment, and treatment must not have started more than 14 days before joining the study. The study follows patients over time to document treatment patterns, dose changes, interruptions, and discontinuations. Participants will attend routine follow-up visits and complete patient-reported outcome questionnaires assessing medication adherence, quality of life, and work productivity at multiple time points up to 24 months. Researchers will measure major molecular response at 12 months as the primary outcome and evaluate various secondary molecular responses, reasons for treatment changes, and quality of life scores. The study duration extends through September 2030, allowing long-term observation of treatment effectiveness and safety.

Researchers are evaluating the effects of a partially hydrolyzed formula with synbiotics on infants at risk of allergy, specifically aiming to stop early signs of the allergic march such as atopic dermatitis. This study focuses on infants up to 14 days old who have a family history of allergy and seeks to assess both the efficacy and safety of this formula in improving skin barrier function. Participants will be randomly assigned to one of three groups a partially hydrolyzed formula with synbiotics, an intact protein formula without synbiotics, or a breastfed reference group not applicable in France. The study compares these feeding methods to observe their impact on skin health and allergy development during the first year of life. Throughout the study, infants will be monitored from enrollment until 12 to 13 months of age. Evaluations include measuring skin water loss, skin hydration, severity of atopic dermatitis, immune responses, microbiome analysis, and growth parameters like weight, height, and head circumference. Safety assessments and allergic manifestations will also be tracked to better understand the effects of the formulas and breastfeeding on allergy risk.

Researchers are evaluating the non-inferiority of minimally invasive radical hysterectomy compared to abdominal radical hysterectomy in patients with early-stage cervical cancer. This prospective, randomized, multicenter trial includes patients with specific cervical cancer types and stages, aiming to compare disease-free survival as the primary outcome. Secondary outcomes include overall survival, disease recurrence, quality of life, complications, and serious adverse events. Participants are randomly assigned to one of two groups the experimental arm receives laparoscopic or robot-assisted radical or simple hysterectomy, while the control arm undergoes abdominal radical or simple hysterectomy. Both arms follow guidelines for lymph node dissection or sentinel lymph node biopsy, with specific protective measures for the minimally invasive approach. Surgery type may vary depending on tumor risk according to SHAPE criteria. During the study, patients will be followed for at least five years after surgery. Assessments include survival outcomes, disease recurrence starting six months post-surgery, quality of life questionnaires, lymphatic side effects, complications, adverse events, and health care cost analysis. Monitoring will continue up to one year for complications and serious adverse events, ensuring comprehensive evaluation of treatment effects and safety over time.

Researchers are studying the quality of life and safety of the fully resorbable TIGRae Matrix in women who have undergone implant-based breast reconstruction surgery after mastectomy. This observational, national, multicenter, prospective study aims to collect data on patient-reported outcomes and complications related to this surgical mesh device. Participants will have had the TIGRae Matrix used during their breast reconstruction either as primary or secondary surgery. The study monitors quality of life using the BREAST-Q questionnaire at multiple time points after surgery, including 6, 12, 24, and 36 months. It also tracks complication rates, hospital stay duration, cosmetic outcomes, and any unplanned additional surgeries over three to five years. During the study, participants will complete questionnaires about their quality of life and undergo follow-up assessments to document complications and cosmetic results. Researchers will observe outcomes for up to five years after surgery. The primary focus is on quality of life measured 12 months post-surgery, with additional long-term monitoring to ensure safety and effectiveness of the device.

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

Researchers are studying severe asthma by creating a detailed clinical registry to better understand and improve care for patients with this condition. The German Asthma Net e.V. focuses on gathering reliable data on the incidence, prevalence, different types, and treatments of severe asthma. This registry helps connect several clinics and practices across Germany to optimize diagnosis and treatment for patients. Information collected includes sociodemographic data like gender and birthdate, medical details such as diagnosis and therapies, and measures of lung function, allergy markers, asthma control, smoking status, and related treatments. Data are collected at the initial visit and then yearly for up to 15 years to track progress and changes. Participants receive a unique study ID to keep their personal health information confidential. Researchers will regularly assess asthma symptoms, lung function, medication changes, quality of life, and healthcare usage over the study period. The long-term follow-up allows monitoring of asthma control and related health outcomes in detail.