Hildesheim

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 effects of the drug imlunestrant LY3484356 in premenopausal women with early estrogen receptor-positive ER, HER2-negative breast cancer. The study includes two groups one that explores imlunestrant alone or combined with ovarian suppression, and another that studies imlunestrant without ovarian suppression. The trial compares imlunestrants impact on breast cancer cells and ovarian function to tamoxifen, a known treatment. Participants in Cohort 1 will receive imlunestrant orally either alone or with goserelin a drug given by injection to suppress ovarian function for up to 29 days. Some in this group will take tamoxifen orally as a comparator. Cohort 2 participants will take imlunestrant or tamoxifen orally for up to 6 months without ovarian suppression. The study is open-label, randomized, and phase 2, designed to assess treatment effects in parallel groups. During the study, participants will provide tumor samples before and during treatment, and researchers will monitor changes in specific cancer markers like Ki-67, estrogen receptor ER, and progesterone receptor PR expression. They will also track the rate of ovarian cysts up to 180 days. Participants must attend scheduled visits for evaluations, including performance status checks and safety assessments. The trial is expected to continue until December 2029.

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 collecting data in a registry study for adults diagnosed with acute myeloid leukemia AML, including newly diagnosed and relapsed cases. The study aims to gather important information about the diseases epidemiology, such as patient age and prognostic factors, and to compare incidence and age distribution with population tumor registry data. It also evaluates key clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival. This observational study does not involve treatment assignment but documents treatment strategies used by patients. Data is gathered over a 10-year period to thoroughly monitor outcomes and disease patterns. The registry also collects information on complete remission rates, treatment-related mortality, therapy-associated morbidity, and quality of therapy and diagnosis. Additionally, the study seeks to validate known prognostic factors and explore new ones while describing new therapies and supportive care measures. Participants are adults aged 18 years and older diagnosed with AML according to WHO criteria, including acute promyelocytic leukemia. The study involves long-term follow-up with yearly assessments over 10 years. Researchers will evaluate epidemiological parameters and important survival outcomes. Since this is an observational registry, participants continue with their usual care while data is collected. The study is sponsored by Technische Universitt Dresden and involves multiple sites in Germany.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Researchers are evaluating whether formalized data assessment and systematic feedback can improve treatment times and survival rates for patients with ST-segment elevation myocardial infarction STEMI. The study focuses on reducing time intervals from patient contact to balloon inflation during percutaneous coronary intervention PCI and aims to enhance outcomes through continuous performance feedback in a multicenter setting. This project is structured in multiple phases to test, implement, and advance these feedback methods across various hospitals with PCI capability. The study includes a behavioral intervention where data on treatment times and clinical outcomes are collected and analyzed quarterly. These results are shared with cardiology, emergency department, and emergency medical services staff in interactive sessions to identify and address areas for improvement. The trial spans several phases an initial pilot phase, an implementation phase involving multiple centers, and an advanced phase developing an automated, standardized feedback tool. Feedback sessions occur quarterly or annually depending on the phase. Participants are all patients diagnosed with STEMI and transferred to PCI centers for treatment. The study collects web-based data on time from first medical contact to balloon inflation over consecutive three-month periods. Researchers measure treatment times as the primary outcome and mortality rates at hospital discharge, 30 days, and one year as secondary outcomes. The study involves repeated data feedback sessions to hospital and emergency staff and aims to monitor and improve care quality over time through systematic evaluation.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

Immune thrombocytopenia ITP is a rare blood disorder caused by an autoimmune condition that reduces platelet counts, increasing the risk of bleeding or prolonged bleeding. New treatments for ITP have emerged recently, but existing clinical studies are limited in their applicability to everyday patient care due to strict criteria. This registry aims to collect real-world clinical data and biospecimens from patients with various types of ITP to improve understanding of diagnosis, therapy, and patient outcomes in routine treatment. The registry includes patients diagnosed with primary or secondary ITP who consent to participate. Data collection occurs at defined points in the disease course either prospectively or retrospectively up to 12 months after diagnosis, provided continuous documentation is available. Biospecimens are collected and stored systematically to support research. Clinical information collected includes disease characteristics, treatment types, complications, quality of life, fatigue scores, and survival data over a follow-up period of up to 5 years. Participants provide clinical data and biosamples at enrollment, then again at 6 months and annually for up to 5 years. Assessments include platelet counts, bleeding and thromboembolic events, laboratory markers such as specific antibodies, and patient-reported outcomes like quality of life and fatigue. The study gathers epidemiological data on incidence, age, sex distribution, causes of ITP, treatment received, and remission status. The registry helps advance knowledge about ITP through long-term monitoring and standardized data collection.

Researchers are evaluating the addition of letrozole, an aromatase inhibitor, to the standard maintenance therapy in women diagnosed with estrogen-receptor ER positive epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. This study focuses on both low and high grade serous or endometrioid ovarian cancers at FIGO Stage II-IV, whose cancer has not progressed after primary surgery and platinum-based chemotherapy. The main goal is to determine if letrozole can increase progression-free survival compared to the current standard maintenance treatment with placebo. Participants are randomly assigned to receive either letrozole 2.5 mg daily or a placebo tablet once daily for up to five years or until toxicity symptoms or disease progression occur. This randomized, double-blinded, multicenter phase III trial involves 540 eligible women who will be monitored throughout the treatment period. The study also includes a sub-study focusing on low grade ovarian cancer LOGOS. Treatment adherence and tolerability will be assessed during regular visits. Participants will undergo health assessments including blood tests, physical and gynecological exams, and possibly imaging during routine follow-ups every 12 weeks for the first two years, then every 24 weeks for three additional years. Quality of life will be evaluated using specific questionnaires, and participants will wear an activity tracker for one week before visits. Researchers will measure progression-free survival as the primary outcome and also evaluate overall survival, time to next treatment, and quality-adjusted survival. Follow-up data will be collected for up to 12 years, including up to seven years after treatment ends to monitor long-term outcomes.