Palencia

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 and safety of subcutaneous immunotherapy for people aged 12 to 65 who have mild to moderate allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. Participants are sensitized to grass and olive pollen, and the study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. The study aims to measure combined symptoms and medication scores over 12 months to assess treatment impact. The study includes three groups receiving different treatments: two doses of purified and polymerized allergen extracts from a mixture of grasses and olive pollen (10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517) and a placebo group receiving a similar solution without active ingredients. Treatments are administered subcutaneously over one year. The study is double-blinded and controlled to compare safety and efficacy across groups. Participants will be involved for one year, during which they will record their symptoms and medication use via a smartphone app. Researchers will conduct clinical evaluations, skin tests, and measure specific IgE levels to monitor allergic responses. The main outcome is the Combined Symptoms and Medication Score (CSMS) after 12 months. Safety and treatment adherence will be closely monitored throughout the study period.

Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, sensitized to cupressaceae and grass pollens. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to compare active treatments with a placebo over an 18-month period. The study focuses on reducing symptoms and medication use during the pollen seasons of cupressaceae (January to March) and grasses (May to June). Participants will receive one of three treatments: two different doses of purified and polymerized allergen extracts from a mix of grasses and cupressaceae, or a placebo that looks the same but contains no active ingredients. These treatments are given as subcutaneous injections. Each participant will be treated and monitored for 18 months, covering multiple pollen seasons with continuous dosing. During the study, participants will track their symptoms and medication use daily using an electronic diary on their smartphone. Researchers will assess combined symptom and medication scores to measure treatment effects during pollen seasons. Safety and adherence will be monitored throughout the 18 months. The study involves 180 participants and includes various clinical assessments to ensure accurate evaluation of treatment impact and participant wellbeing.

Researchers are conducting a multicenter cohort study to collect long-term information from female patients diagnosed with early-stage invasive breast cancer. These patients were previously included in neoadjuvant or adjuvant clinical trials conducted by the GEICAM group. The study aims to describe the long-term evolution and outcomes of these patients over approximately 30 years of follow-up, providing valuable data on treatment effects and any late-occurring consequences beyond initial analyses. The study involves patients who completed follow-up from their original neoadjuvant or adjuvant GEICAM clinical trials starting from 1998. Participants will be observed for up to 30 years to thoroughly assess event-free survival in neoadjuvant studies and disease-free survival in adjuvant studies. This extended monitoring period allows researchers to evaluate the long-term efficacy and safety of treatments received during those trials. Throughout the study, participants' health status will be regularly assessed to monitor survival outcomes and any disease recurrence. Information such as survival without events and disease-free survival will be collected and tracked across the entire follow-up period. The long-term data gathered will support healthcare professionals, patients, and society in understanding breast cancer progression and the lasting impact of treatments over decades.

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), involves chronic inflammation in different parts of the digestive tract, causing relapsing symptoms. The inflammatory process features increased activated granulocytes and monocyte-macrophages, which contribute to tissue damage. Granulocytapheresis (GMA) is being studied as a treatment alternative, especially for patients dependent on corticosteroids, to reduce inflammation by selectively removing these inflammatory cells from the blood. The study evaluates the use of the Adacolumn4 medical device for GMA therapy in adults diagnosed with UC or CD under real-world conditions. Patients will receive GMA sessions typically once a week for five weeks, with some receiving more frequent or maintenance sessions depending on their condition. The treatment aims to decrease the need for steroids and may be combined with other therapies. The study includes up to four visits: baseline, 1 month, 6 months, and 12 months after the final induction session. Participants will be monitored through routine clinical visits without extra interventions beyond usual care. Data collected include clinical remission rates without steroids six months after GMA therapy, safety information, changes in treatment, and quality of life measures. The total follow-up after treatment completion is approximately 12 months, ensuring careful observation of treatment effects and patient well-being.

Researchers are conducting an observational study called SOGUG-PRINCIS to collect and analyze data on the effectiveness of drugs recently approved for treating genitourinary tumors under routine clinical practice in Spain. This national, multicenter study includes both retrospective patient data and prospective follow-up, aiming to validate real-world outcomes compared to those reported in phase III clinical trials. The study covers cancers originating in the kidney, ureter, bladder, prostate, testicle, urethra, penis, and seminal vesicles. The study observes patients treated with drugs such as darolutamide combined with androgen deprivation therapy and docetaxel, adjuvant nivolumab after surgical removal of urothelial carcinoma, and enfortumab vedotin. All treatments follow their approved dosing and administration guidelines in standard clinical practice. New subprojects may be added as new drugs gain funding approval by the Spanish National Health System, with each subproject focusing on specific primary endpoints. Participants' involvement includes treatment decisions made independently from the study, with data collected afterward to assess outcomes. Researchers will track progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after treatment initiation. The study also serves as a registry for genitourinary cancer treatments funded nationally, supporting long-term evaluation of drug effectiveness in real-world settings.

This trial focuses on adult patients aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph-negative ALL). The study evaluates treatment approaches based on measurable residual disease (MRD) and genetic analysis done at the start. The goal is to determine the best continuation therapy after initial consolidation treatment to improve overall survival over three years. Participants first receive a uniform four-drug induction chemotherapy including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Patients who do not respond adequately receive a second induction with fludarabine, Ara-C, G-CSF, and idarubicin (FLAG-IDA). Those with good MRD clearance proceed through early consolidation, delayed intensification, reinduction, and maintenance phases with pediatric-type chemotherapy drugs. Patients with less favorable MRD or genetic profiles may receive early or delayed allogeneic hematopoietic stem cell transplantation (alloHSCT). Throughout the study, participants undergo regular monitoring of disease status and response to therapy. Researchers assess overall survival at three years as the primary outcome. Patients' health status, treatment adherence, and side effects are closely followed. The study aims to personalize treatment plans based on MRD and genetics to optimize outcomes for adults with Ph-negative ALL.