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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a prospective, multicenter observational study to create a registry for patients with unresectable locally advanced or metastatic breast cancer. This study includes patients diagnosed from January 2016 onwards, either at first diagnosis or after recurrence. Treatment choices are made independently by physicians, and the study does not specify any treatment regimen. The study groups are defined by breast cancer subtypes based on receptor expression, including Luminal A-like, Luminal B-like HER2 negative and positive, HER2-enriched, and Triple Negative subtypes. Since this is an observational study, patients receive standard care as determined by their doctors, and no intervention is assigned by the study. Participants medical records and disease management data will be collected and reviewed over an 8-year period. Researchers will evaluate the distribution of breast cancer subtypes, patient and tumor characteristics, hereditary risk factors, gender differences in disease progression, timing of primary tumor surgery, and biomarker presence in tumor and blood samples. Patients may withdraw consent at any time, and the study aims to follow patients until death or study completion.
Actively Recruiting
This observational study aims to describe the use of teclistamab and talquetamab in treating patients with relapsed or refractory multiple myeloma RRMM outside of clinical trial settings. It collects real-world data to better understand how these treatments are used and their outcomes in typical healthcare environments. The study enrolls participants who have received at least one dose of teclistamab or talquetamab outside clinical trials during specified time periods from before December 2022 through December 2025. No study interventions are administered instead, researchers analyze existing medical records to document treatment details and patient experiences with these therapies. Participants medical records are reviewed to capture baseline characteristics, response rates, time to response, duration of response, survival outcomes, safety management, and treatment use up to 40 months. The study focuses on collecting comprehensive retrospective data without requiring active treatment or additional procedures, providing insight into real-world treatment patterns and outcomes for RRMM patients.
Actively Recruiting
Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups one receiving 10,000 TUmL MG01 plus 10,000 TUmL T517, another receiving 30,000 TUmL MG01 plus 10,000 TUmL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in patients aged 12 to 65 who have rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, and who are sensitive to cupressaceae and grass pollen. This phase 3, multicenter, randomized, double-blinded, placebo-controlled trial aims to better understand treatment options for allergy symptoms related to these pollens. Participants will be randomly assigned to one of three groups two groups receiving different doses of a purified and polymerized allergen extract from grasses and cupressaceae mixed with aluminum hydroxide, and one placebo group receiving a similar solution without active ingredients. The treatment will be given by subcutaneous injections and will last for 18 months. The study will monitor symptoms and medication use during the specific pollen seasons for cupressaceae January to March and grasses May to June. Throughout the trial, participants will record their symptoms and medication intake using an electronic diary via a smartphone. Researchers will assess combined symptom and medication scores as the primary outcome, along with various secondary measures such as symptom-free days, medication-free days, asthma and rhinitis symptom scores, quality of life, immunological parameters, and safety. The total participation time for each subject is 18 months, during which their health and response to treatment will be closely monitored.
Actively Recruiting
Researchers are studying patients with splenomegaly or those who have had a splenectomy without a known cause, focusing on the possible presence of Gaucher disease GD and Acid Sphingomyelinase Deficiency ASMD. These conditions may be linked to monoclonal gammopathy of undetermined significance MGUS and multiple myeloma MM, which have been found more frequently among Gaucher and ASMD patients. The study aims to improve diagnosis of unknown causes of splenomegaly and undiagnosed cases of MGUS or MM in these patients. The study involves using standard diagnostic procedures for unknown splenomegaly and splenectomy patients, including collecting blood samples for a dry drop test DBS. This test measures enzymatic and genetic activity related to Gaucher disease and ASMD, alongside analysis of LisoGl1 and LisoSM biomarkers. No specific treatment or intervention is applied since this is an observational study. Participants will undergo clinical evaluations and blood sampling to help identify the prevalence of Gaucher disease and ASMD over a 36-month period. Researchers will track how many patients with unknown splenomegaly or MGUSMM have these enzyme deficiencies. The study is observational, with no treatment assigned, and participants will be monitored during their routine medical consultations throughout the study duration.
Actively Recruiting
Researchers are studying how inflammatory bowel disease IBD activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study aims to understand if frailty and related risks like hospitalization and mortality can be reversed with proactive treatment in frail patients with active IBD. The study also evaluates which frailty index best predicts complications in this population. At the start, four clinical frailty indices will be calculated for each participant, alongside recording clinical variables related to IBD and other health conditions. Patients will be followed through three visits at 3, 6, and 12 months, during which frailty, disease activity, treatment changes, adverse effects, hospitalizations, and mortality will be reassessed to track progress and outcomes. Participants will be involved in these visits where various assessments will be done, including measuring frailty and comorbidities and reviewing their IBD activity and treatments. The main outcomes include assessing the impact of IBD activity on frailty and how frailty affects hospitalization and mortality risk over a 12-month period. The study is led by the Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and runs until May 2027.
Actively Recruiting
Researchers are studying adults aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia Ph-negative ALL. The study evaluates treatment outcomes based on measurable residual disease MRD status and genetic testing done at the start. The goal is to tailor therapy after initial consolidation to improve survival and remission rates. Patients initially receive a four-drug induction chemotherapy regimen including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Those who do not respond may receive a second induction with fludarabine, cytarabine, G-CSF, and idarubicin. Patients with good MRD clearance and favorable genetics continue with early and delayed consolidation, reinduction, and maintenance chemotherapy using pediatric-type protocols. Others may proceed to allogeneic hematopoietic stem cell transplantation alloHSCT. Participants will undergo regular assessments of MRD after induction and consolidation phases, along with monitoring for complete remission at 4 to 8 weeks. Researchers will track overall survival for 3 years. Safety and treatment responses are evaluated throughout, with ongoing follow-up. The total study duration includes treatment periods and observation to assess long-term outcomes under the guidance of the PETHEMA Foundation.